Browsing by Author "Patkar, Ashwin A"

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Open Access
Addressing the Side Effects of Contemporary Antidepressant Drugs: A Comprehensive Review.
(Chonnam medical journal, 2018-05-25) Wang, Sheng-Min; Han, Changsu; Bahk, Won-Myoung; Lee, Soo-Jung; Patkar, Ashwin A; Masand, Prakash S; Pae, Chi-Un
Randomized trials have shown that selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have better safety profiles than classical tricyclic antidepressants (TCAs). However, an increasing number of studies, including meta-analyses, naturalistic studies, and longer-term studies suggested that SSRIs and SNRIs are no less safe than TCAs. We focused on comparing the common side effects of TCAs with those of newer generation antidepressants including SSRIs, SNRIs, mirtazapine, and bupropion. The main purpose was to investigate safety profile differences among drug classes rather than the individual antidepressants, so studies containing comparison data on drug groups were prioritized. In terms of safety after overdose, the common belief on newer generation antidepressants having fewer side effects than TCAs appears to be true. TCAs were also associated with higher drop-out rates, lower tolerability, and higher cardiac side-effects. However, evidence regarding side effects including dry mouth, gastrointestinal side effects, hepatotoxicity, seizure, and weight has been inconsistent, some studies demonstrated the superiority of SSRIs and SNRIs over TCAs, while others found the opposite. Some other side effects such as sexual dysfunction, bleeding, and hyponatremia were more prominent with either SSRIs or SNRIs.
Open Access
An integrated alcohol abuse and medical treatment model for patients with hepatitis C.
(Dig Dis Sci, 2012-04) Proeschold-Bell, Rae Jean; Patkar, Ashwin A; Naggie, Susanna; Coward, Lesleyjill; Mannelli, Paolo; Yao, Jia; Bixby, Patricia; Muir, Andrew J
BACKGROUND: Patients with chronic hepatitis C virus (HCV) infection have high rates of alcohol consumption, which is associated with progression of fibrosis and lower response rates to HCV treatment. AIMS: This prospective cohort study examined the feasibility of a 24-week integrated alcohol and medical treatment to HCV-infected patients. METHODS: Patients were recruited from a hepatology clinic if they had an Alcohol Use Disorders Identification Test score >4 for women and >8 for men, suggesting hazardous alcohol consumption. The integrated model included patients receiving medical care and alcohol treatment within the same clinic. Alcohol treatment consisted of 6 months of group and individual therapy from an addictions specialist and consultation from a study team psychiatrist as needed. RESULTS: Sixty patients were initially enrolled, and 53 patients participated in treatment. The primary endpoint was the Addiction Severity Index (ASI) alcohol composite scores, which significantly decreased by 0.105 (41.7% reduction) between 0 and 3 months (P < 0.01) and by 0.128 (50.6% reduction) between 0 and 6 months (P < 0.01) after adjusting for covariates. Alcohol abstinence was reported by 40% of patients at 3 months and 44% at 6 months. Patients who did not become alcohol abstinent had reductions in their ASI alcohol composite scores from 0.298 at baseline to 0.219 (26.8% reduction) at 6 months (P = 0.08). CONCLUSION: This study demonstrated that an integrated model of alcohol treatment and medical care could be successfully implemented in a hepatology clinic with significant favorable impact on alcohol use and abstinence among patients with chronic HCV.
Open Access
An item response theory modeling of alcohol and marijuana dependences: a National Drug Abuse Treatment Clinical Trials Network study.
(Journal of studies on alcohol and drugs, 2009-05) Wu, Li-Tzy; Pan, Jeng-Jong; Blazer, Dan G; Tai, Betty; Stitzer, Maxine L; Brooner, Robert K; Woody, George E; Patkar, Ashwin A; Blaine, Jack D
OBJECTIVE:The aim of this study was to examine psychometric properties of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnostics criteria for alcohol and marijuana dependences among 462 alcohol users and 311 marijuana users enrolled in two multisite trials of the National Drug Abuse Treatment Clinical Trials Network. METHOD:Diagnostic questions were assessed by the DSM-IV checklist. Data were analyzed by the item response theory and the multiple indicators-multiple causes method procedures. RESULTS:Criterion symptoms of alcohol and marijuana dependences exhibited a high level of internal consistency. All individual symptoms showed good discrimination in distinguishing alcohol or marijuana users between high and low severity levels of the continuum. In both groups, "withdrawal" appeared to measure the most severe symptom of the dependence continuum. There was little evidence of measurement nonequivalence in assessing symptoms of dependence by gender, age, race/ethnicity, and educational level. CONCLUSIONS:These findings highlight the clinical utility of the DSM-IV checklist in assessing alcohol- and marijuana dependence syndromes among treatment-seeking substance users.
Open Access
Early outcomes following low dose naltrexone enhancement of opioid detoxification.
(The American journal on addictions, 2009-03) Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathleen; Gottheil, Edward; Wu, Li-Tzy; Gorelick, David A
Although withdrawal severity and treatment completion are the initial focus of opioid detoxification, post-detoxification outcome better defines effective interventions. Very low dose naltrexone (VLNTX) in addition to methadone taper was recently associated with attenuated withdrawal intensity during detoxification. We describe the results of a seven-day follow-up evaluation of 96 subjects who completed inpatient detoxification consisting of the addition of VLNTX (0.125 or 0.250 mg per day) or placebo to methadone taper in a double blind, randomized investigation. Individuals receiving VLNTX during detoxification reported reduced withdrawal and drug use during the first 24 hours after discharge. VLNTX addition was also associated with higher rates of negative drug tests for opioids and cannabis and increased engagement in outpatient treatment after one week. Further studies are needed to test the utility of this approach in easing the transition from detoxification to various follow-up treatment modalities designed to address opioid dependence.
Open Access
Effectiveness of low-dose naltrexone in the post-detoxification treatment of opioid dependence.
(Journal of clinical psychopharmacology, 2007-10) Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathleen; Murray, Heather W; Wu, Li-Tzy; Hubbard, Robert
BACKGROUND: The clinical use of naltrexone (NTX) in the treatment of opioid dependence has been limited because of poor compliance and inconsistent outcomes. In particular, the therapeutic benefit of extended treatment with NTX after opioid detoxification is unclear. The present study evaluated whether the augmentation with low-dose NTX during the post-detoxification treatment of opioid dependence would improve outcomes. METHODS: In an open-label naturalistic design, 435 opioid-dependent patients who had completed inpatient detoxification were offered the choice of entering 1 of the 2 outpatient treatment arms: clonidine extended treatment (CET) (clonidine + psychosocial treatment), or enhanced extended treatment (EET) (oral NTX [1-10 mg/d] + CET) for 21 days. The primary outcome measure was retention in treatment. Secondary outcomes included abstinence from opioids, dropouts, and adherence to postdischarge care. RESULTS: One hundred sixty-two patients (37.2%) accepted EET. Subjects receiving EET stayed longer in the program (F = 64.4; P = 0.000), were less likely to drop out, used less opioids, and followed through with referral to long-term outpatient treatment in a higher number, compared with patients in the CET arm (P = 0.000 in each case). The NTX + clonidine combination was safe and well tolerated. CONCLUSIONS: This preliminary study indicates the potential benefit of augmentation with low-dose NTX to improve outcomes after opioid detoxification for a preferred group of patients. Randomized controlled trials are necessary to further evaluate the role of low-dose NTX in the outpatient treatment of opioid dependence.
Open Access
Guidance for switching from off-label antipsychotics to pimavanserin for Parkinson's disease psychosis: an expert consensus.
(CNS spectrums, 2018-12) Black, Kevin J; Nasrallah, Henry; Isaacson, Stuart; Stacy, Mark; Pahwa, Rajesh; Adler, Charles H; Alva, Gustavo; Cooney, Jeffrey W; Kremens, Daniel; Menza, Matthew A; Meyer, Jonathan M; Patkar, Ashwin A; Simuni, Tanya; Morrissette, Debbi A; Stahl, Stephen M
Patients with Parkinson's disease psychosis (PDP) are often treated with an atypical antipsychotic, especially quetiapine or clozapine, but side effects, lack of sufficient efficacy, or both may motivate a switch to pimavanserin, the first medication approved for management of PDP. How best to implement a switch to pimavanserin has not been clear, as there are no controlled trials or case series in the literature to provide guidance. An abrupt switch may interrupt partially effective treatment or potentially trigger rebound effects from antipsychotic withdrawal, whereas cross-taper involves potential drug interactions. A panel of experts drew from published data, their experience treating PDP, lessons from switching antipsychotic drugs in other populations, and the pharmacology of the relevant drugs, to establish consensus recommendations. The panel concluded that patients with PDP can be safely and effectively switched from atypical antipsychotics used off label in PDP to the recently approved pimavanserin by considering each agent's pharmacokinetics and pharmacodynamics, receptor interactions, and the clinical reason for switching (efficacy or adverse events). Final recommendations are that such a switch should aim to maintain adequate 5-HT2A antagonism during the switch, thus providing a stable transition so that efficacy is maintained. Specifically, the consensus recommendation is to add pimavanserin at the full recommended daily dose (34 mg) for 2-6 weeks in most patients before beginning to taper and discontinue quetiapine or clozapine over several days to weeks. Further details are provided for this recommendation, as well as for special clinical circumstances where switching may need to proceed more rapidly.
Open Access
Hallucinogen use disorders among adult users of MDMA and other hallucinogens.
(The American journal on addictions, 2008-09) Wu, Li-Tzy; Ringwalt, Christopher L; Mannelli, Paolo; Patkar, Ashwin A
We investigated the prevalence, patterns, and correlates of past-year DSM-IV hallucinogen use disorders (HUDs) among past-year users of MDMA and other hallucinogens from a sample of Americans 18 or older (n = 37,227). Users were categorized as MDMA users and other hallucinogen users. Overall, one in five (20%) MDMA users and about one in six (16%) other hallucinogen users reported at least one clinical feature of HUDs. Among MDMA users, prevalence of hallucinogen abuse, subthreshold dependence, and dependence was 4.9%, 11.9%, and 3.6%, respectively. The majority with hallucinogen abuse displayed subthreshold dependence. Most with hallucinogen dependence exhibited abuse. Subthreshold hallucinogen dependence is relatively prevalent and represents a clinically important subgroup that warrants future research and consideration in a major diagnostic classification system.
Open Access
Heterogeneity of stimulant dependence: a national drug abuse treatment clinical trials network study.
(The American journal on addictions, 2009-05) Wu, Li-Tzy; Blazer, Dan G; Patkar, Ashwin A; Stitzer, Maxine L; Wakim, Paul G; Brooner, Robert K
We investigated the presence of DSM-IV subtyping for dependence on cocaine and amphetamines (with versus without physical dependence) among outpatient stimulant users enrolled in a multisite study of the Clinical Trials Network (CTN). Three mutually exclusive groups were identified: primary cocaine users (n = 287), primary amphetamine users (n = 99), and dual users (cocaine and amphetamines; n = 29). Distinct subtypes were examined with latent class and logistic regression procedures. Cocaine users were distinct from amphetamine users in age and race/ethnicity. There were four distinct classes of primary cocaine users: non-dependence (15%), compulsive use (14%), tolerance and compulsive use (15%), and physiological dependence (tolerance, withdrawal, and compulsive use; 56%). Three distinct classes of primary amphetamine users were identified: non-dependence (11%), intermediate physiological dependence (31%), and physiological dependence (58%). Regardless of stimulants used, most female users were in the most severe or the physiological dependence group. These results lend support for subtyping dependence in the emerging DSM-V.
Open Access
Infrequent illicit methadone use among stimulant-using patients in methadone maintenance treatment programs: a national drug abuse treatment clinical trials network study.
(The American journal on addictions, 2008-07) Wu, Li-Tzy; Blazer, Dan G; Stitzer, Maxine L; Patkar, Ashwin A; Blaine, Jack D
We sought to determine the prevalence, patterns, and correlates of past-month illicit methadone use and history of regular illicit use among stimulant-using methadone maintenance treatment patients. We obtained self-reported information on illicit methadone use from 383 participants recruited from six community-based methadone maintenance programs. Overall, 1.6% of participants reported illicit use in the past month, and 4.7% reported a history of regular use. Younger age and history of outpatient psychological treatment were associated with increased odds of past-month illicit use. Illicit methadone use among patients in maintenance programs is infrequent; however, a number of factors may increase risk of illicit use.
Open Access
Non-invasive brain stimulation modalities for the treatment and prevention of opioid use disorder: a systematic review of the literature
(Journal of Addictive Diseases, 2020-01-01) Young, Jonathan R; Smani, Shayan A; Mischel, Nicholas A; Kritzer, Michael D; Appelbaum, Lawrence G; Patkar, Ashwin A
© 2020, © 2020 Taylor & Francis Group, LLC. The U.S. is currently facing an unprecedented epidemic of opioid-related deaths. Despite the efficacy of the current treatments for opioid use disorder (OUD), including psychosocial interventions and medication-assisted therapy (MAT), many patients remain treatment-resistant and at high risk for overdose. A potential augmentation strategy includes the use of non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), and auricular vagus nerve stimulation (aVNS). These approaches may have therapeutic benefits by directly or indirectly modulating the neurocircuitry affected in OUD. In this review, we evaluate the available studies on NIBS in the context of OUD withdrawal and detoxification, maintenance, and cravings, while also considering analgesia and safety concerns. In the context of opioid withdrawal and detoxification, a percutaneous form of aVNS has positive results in open-label trials, but has not yet been tested against sham. No randomized studies have reported on the safety and efficacy of NIBS specifically for maintenance treatment in OUD. TMS and tDCS have demonstrated effects on cravings, although published studies were limited by small sample sizes. NIBS may play a role in reducing exposure to opioids and the risk of developing OUD, as demonstrated by studies using tDCS in an experimental pain condition and TMS in a post-operative setting. Overall, while the preliminary evidence and safety for NIBS in the prevention and treatment of OUD appears promising, further research is needed with larger sample sizes, placebo control, and objective biomarkers as outcome measures before strong conclusions can be drawn.
Open Access
Non-prescribed use of pain relievers among adolescents in the United States.
(Drug and alcohol dependence, 2008-04) Wu, Li-Tzy; Pilowsky, Daniel J; Patkar, Ashwin A
We examined gender-specific prevalences, patterns, and correlates of non-prescribed use of pain relievers - mainly opioids - in a representative sample of American adolescents (N=18,678).Data were drawn from the public use data file of the 2005 U.S. National Survey on Drug Use and Health, a survey of non-institutionalized American household residents. The patterns of non-prescribed use of prescription pain relievers were examined, and logistic regression procedures were conducted to identify correlates of non-prescribed use.Approximately one in 10 adolescents aged 12-17 years reported non-prescribed use of pain relievers in their lifetime (9.3% in males and 10.3% in females). The mean age of first non-prescribed use was 13.3 years, which was similar to the mean age of first use of alcohol and marijuana but older than the age of first inhalant use. Among all non-prescribed users, 52% reported having used hydrocodone products (Vicodin, Lortab, Lorcet, and Lorcet Plus, and hydrocodone), 50% had used propoxyphene (Darvocet or Darvon) or codeine (Tylenol with codeine), and 24% had used oxycodone products (OxyContin, Percocet, Percodan, and Tylox). Approximately one quarter (26%) of all non-prescribed users had never used other non-prescribed or illicit drugs. There were gender variations in correlates of non-prescribed use.Use of non-prescribed pain relievers occurs early in adolescence. Research is needed to understand whether early use of non-prescribed pain relievers is related to later drug use.
Open Access
Prescription pain reliever abuse and dependence among adolescents: a nationally representative study.
(Journal of the American Academy of Child and Adolescent Psychiatry, 2008-09) Wu, Li-Tzy; Ringwalt, Christopher L; Mannelli, Paolo; Patkar, Ashwin A
We examined the prevalence, patterns, and correlates of adolescents' abuse, subthreshold dependence ("diagnostic orphans"), and dependence on prescription pain relievers (PPRs) such as opioids in a representative national sample (N = 36,992).Data were from the 2005-2006 National Surveys of Drug Use and Health. DSM-IV criteria for abuse and dependence were examined.Of all adolescents ages 12 to 17, 7% (n = 2,675) reported nonprescribed PPR use in the past year, and 1% (n = 400) met criteria for past-year PPR abuse or dependence. Among the 2,675 adolescents who reported nonprescribed PPR use, more than one in three reported symptoms of abuse or dependence: 7% abuse, 20% subthreshold dependence, and 9% dependence. Regular PPR use, major depressive episodes, and alcohol use disorders were associated with each diagnostic category. Compared with asymptomatic nonprescribed PPR users, increased odds of abuse were noted among nonstudents (adjusted odds ratio [AOR] 2.6), users of mental health services (AOR 1.8), and those reporting poor or fair health (AOR 2.4); and increased odds of dependence were observed among females (AOR 1.6), those who were involved in selling illicit drugs (AOR 1.7), and users of multiple drugs (AOR 2.9). Subthreshold dependent users resembled dependent users in major depressive episodes (AOR 1.5), alcohol use disorders (AOR 1.8), and use of multiple drugs (AOR 1.7).Dependence on PPRs can occur without abuse, and subthreshold dependence deserves to be investigated further for consideration in major diagnostic classification systems.
Open Access
Problem drinking and low-dose naltrexone-assisted opioid detoxification.
(Journal of studies on alcohol and drugs, 2011-05) Mannelli, Paolo; Peindl, Kathleen; Patkar, Ashwin A; Wu, Li-Tzy; Tharwani, Haresh M; Gorelick, David A
OBJECTIVE:The influence of alcohol use on opioid dependence is a major problem that warrants a search for more effective treatment strategies. The addition of very-low-dose naltrexone (VLNTX) to methadone taper was recently associated with reduced withdrawal intensity during detoxification. In a secondary analysis of these data, we sought to determine whether problem drinking affects detoxification outcomes and whether symptoms are influenced by VLNTX use. METHOD:Opioid-dependent patients (N = 174) received naltrexone (0.125 or 0.250 mg/day) or placebo in a double-blind, randomized design during methadone-based, 6-day inpatient detoxification. Alcohol consumption was assessed at admission using the Addiction Severity Index and selfreport. Outcome measures were opioid withdrawal intensity, craving, and retention in treatment. RESULTS:Problem drinking-opioid dependent patients (n = 79) showed episodic heavy alcohol use and reported increased subjective opioid withdrawal intensity (p = .001), craving (p = .001), and significantly lower rate of retention in treatment (p = .02). Individuals with problem drinking and opioid dependence who were treated with VLNTX (n = 55) showed reduced withdrawal (p = .05) and a lower rate of treatment discontinuation (p = .03), resuming alcohol intake in smaller numbers the day following discharge (p = .03). Treatment effects were more pronounced on anxiety, perspiration, shakiness, nausea, stomach cramps, and craving. There were no group differences in use of adjuvant medications and no treatment-related adverse events. CONCLUSIONS:Heavy drinking is associated with worse opioid detoxification outcomes. The addition of VLNTX is safe and is associated with reduced withdrawal symptoms and better completion rate in these patients. Further studies should explore the use of VLNTX in detoxification and long-term treatment of combined alcohol-opioid dependence and alcohol dependence alone.
Open Access
Reduced cannabis use after low-dose naltrexone addition to opioid detoxification.
(Journal of clinical psychopharmacology, 2010-08) Mannelli, Paolo; Peindl, Kathi; Patkar, Ashwin A; Wu, Li-Tzy; Pae, Chi-Un; Gorelick, David A
Open Access
The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal.
(The American journal of drug and alcohol abuse, 2012-05) Mannelli, Paolo; Peindl, Kathleen; Wu, Li-Tzy; Patkar, Ashwin A; Gorelick, David A
The management of withdrawal absorbs substantial clinical efforts in opioid dependence (OD). The real challenge lies in improving current pharmacotherapies. Although widely used, clonidine causes problematic adverse effects and does not alleviate important symptoms of opioid withdrawal, alone or in combination with the opioid antagonist naltrexone. Very low-dose naltrexone (VLNTX) has been shown to attenuate withdrawal intensity and noradrenaline release following opioid agonist taper, suggesting a combination with clonidine may result in improved safety and efficacy.We investigated the effects of a VLNTX-clonidine combination in a secondary analysis of data from a double-blind, randomized opioid detoxification trial.Withdrawal symptoms and treatment completion were compared following VLNTX (.125 or .25 mg/day) and clonidine (.1-.2 mg q6h) in 127 individuals with OD undergoing 6-day methadone inpatient taper at a community program.VLNTX was more effective than placebo or clonidine in reducing symptoms and signs of withdrawal. The use of VLNTX in combination with clonidine was associated with attenuated subjective withdrawal compared with each medication alone, favoring detoxification completion in comparison with clonidine or naltrexone placebo. VLNTX/clonidine was effective in reducing symptoms that are both undertreated and well controlled with clonidine treatment and was not associated with significant adverse events compared with other treatments.Preliminary results elucidate neurobiological mechanisms of OD and support the utility of controlled studies on a novel VLNTX + low-dose clonidine combination for the management of opioid withdrawal.
Open Access
The construct and measurement equivalence of cocaine and opioid dependences: a National Drug Abuse Treatment Clinical Trials Network (CTN) study.
(Drug and alcohol dependence, 2009-08) Wu, Li-Tzy; Pan, Jeng-Jong; Blazer, Dan G; Tai, Betty; Brooner, Robert K; Stitzer, Maxine L; Patkar, Ashwin A; Blaine, Jack D
INTRODUCTION:Although DSM-IV criteria are widely used in making diagnoses of substance use disorders, gaps exist regarding diagnosis classification, use of dependence criteria, and effects of measurement bias on diagnosis assessment. We examined the construct and measurement equivalence of diagnostic criteria for cocaine and opioid dependences, including whether each criterion maps onto the dependence construct, how well each criterion performs, how much information each contributes to a diagnosis, and whether symptom-endorsing is equivalent between demographic groups. METHODS:Item response theory (IRT) and multiple indicators-multiple causes (MIMIC) modeling were performed on a sample of stimulant-using methadone maintenance patients enrolled in a multisite study of the National Drug Abuse Treatment Clinical Trials Network (CTN) (N=383). Participants were recruited from six community-based methadone maintenance treatment programs associated with the CTN and major U.S. providers. Cocaine and opioid dependences were assessed by DSM-IV Checklist. RESULTS:IRT modeling showed that symptoms of cocaine and opioid dependences, respectively, were arrayed along a continuum of severity. All symptoms had moderate to high discrimination in distinguishing drug users between severity levels. "Withdrawal" identified the most severe symptom of the cocaine dependence continuum. MIMIC modeling revealed some support for measurement equivalence. CONCLUSIONS:Study results suggest that self-reported symptoms of cocaine and opioid dependences and their underlying constructs can be measured appropriately among treatment-seeking polysubstance users.
Open Access
The high prevalence of substance use disorders among recent MDMA users compared with other drug users: Implications for intervention.
(Addictive behaviors, 2009-08) Wu, Li-Tzy; Parrott, Andy C; Ringwalt, Christopher L; Patkar, Ashwin A; Mannelli, Paolo; Blazer, Dan G
In light of the resurgence in MDMA use and its association with polysubstance use, we investigated the 12-month prevalence of substance use disorders (SUDs) among adult MDMA users to determine whether they are at risk of other drug-related problems that would call for targeted interventions.Data were drawn from the 2006 National Survey on Drug Use and Health. Past-year adult drug users were grouped into three mutually exclusive categories: 1) recent MDMA users, who had used the drug within the past year; 2) former MDMA users, who had a history of using this drug but had not done so within the past year; and 3) other drug users, who had never used MDMA. Logistic regression procedures were used to estimate the association between respondents' SUDs and MDMA use while adjusting for their socioeconomic status, mental health, age of first use, and history of polydrug use.Approximately 14% of adults reported drug use in the past year, and 24% of those past-year drug users reported a history of MDMA use. Recent MDMA users exhibited the highest prevalence of disorders related to alcohol (41%), marijuana (30%), cocaine (10%), pain reliever/opioid (8%), and tranquilizer (3%) use. Adjusted logistic regression analyses revealed that, relative to other drug users, those who had recently used MDMA were twice as likely to meet criteria for marijuana and pain reliever/opioid use disorders. They were also about twice as likely as former MDMA users to meet criteria for marijuana, cocaine, and tranquilizer use disorders.Seven out of ten recent MDMA users report experiencing an SUD in the past year. Adults who have recently used MDMA should be screened for possible SUDs to ensure early detection and treatment.
Open Access
The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry.
(Contemporary clinical trials, 2009-03) Han, Changsu; Kwak, Kyung-phil; Marks, David M; Pae, Chi-Un; Wu, Li-Tzy; Bhatia, Kamal S; Masand, Prakash S; Patkar, Ashwin A
To determine whether the CONSORT recommendations influenced the quality of reporting of randomized controlled trials (RCTs) in the field of psychiatry, we evaluated the quality of clinical trial reports before and after the introduction of CONSORT statement. We selected seven high impact journals and retrieved the randomized, clinical trials in the field of psychiatry during the period of 1992-1996 (pre-CONSORT) and 2002-2007 (post-CONSORT). Among the total 5201 articles screened, 736 were identified and entered in our database. After critical review of the publications, 442 articles met the inclusion and exclusion criteria. The CONSORT Index (sum of 22 items of the checklist) during the post-CONSORT period was significantly higher than that during the pre-CONSORT period. However, over 40% of post-CONSORT studies did not adhere to CONSORT statement for reporting the process of randomization, and details of the process for obtaining informed consent were still insufficient. Furthermore, adherence to the CONSORT guidelines of reporting how blinding was accomplished and evaluated actually decreased after publication of the CONSORT statement. Although the overall quality of reporting on psychiatric RCTs generally improved after publication of the CONSORT statement, reporting the details of randomization, blinding, and obtaining informed consent remain insufficient.
Open Access
Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial.
(Addiction biology, 2009-04) Mannelli, Paolo; Patkar, Ashwin A; Peindl, Kathi; Gorelick, David A; Wu, Li-Tzy; Gottheil, Edward
Although current treatments for opioid detoxification are not always effective, medical detoxification remains a required step before long-term interventions. The use of opioid antagonist medications to improve detoxification has produced inconsistent results. Very low dose naltrexone (VLNTX) was recently found to reduce opioid tolerance and dependence in animal and clinical studies. We decided to evaluate safety and efficacy of VLNTX adjunct to methadone in reducing withdrawal during detoxification. In a multi-center, double-blind, randomized study at community treatment programs, where most detoxifications are performed, 174 opioid-dependent subjects received NTX 0.125 mg, 0.250 mg or placebo daily for 6 days, together with methadone in tapering doses. VLNTX-treated individuals reported attenuated withdrawal symptoms [F = 7.24 (2,170); P = 0.001] and reduced craving [F = 3.73 (2,107); P = 0.03]. Treatment effects were more pronounced at discharge and were not accompanied by a significantly higher retention rate. There were no group differences in use of adjuvant medications and no treatment-related adverse events. Further studies should explore the use of VLNTX, combined with full and partial opioid agonist medications, in detoxification and long-term treatment of opioid dependence.