Effectiveness of low-dose naltrexone in the post-detoxification treatment of opioid dependence.

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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.





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Mannelli, Paolo, Ashwin A Patkar, Kathleen Peindl, Heather W Murray, Li-Tzy Wu and Robert Hubbard (2007). Effectiveness of low-dose naltrexone in the post-detoxification treatment of opioid dependence. Journal of clinical psychopharmacology, 27(5). pp. 468–474. 10.1097/jcp.0b013e31814e5e9d Retrieved from https://hdl.handle.net/10161/20043.

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Paolo Mannelli

Professor of Psychiatry and Behavioral Sciences

Li-Tzy Wu

Professor in Psychiatry and Behavioral Sciences

Education/Training: Pre- and post-doctoral training in mental health service research, psychiatric epidemiology (NIMH T32), and addiction epidemiology (NIDA T32) from Johns Hopkins University School of Public Health (Maryland); Fellow of the NIH Summer Institute on the Design and Conduct of Randomized Clinical Trials.

Director: Duke Community Based Substance Use Disorder Research Program.

Research interests: COVID-19, Opioid misuse, Opioid overdose, Opioid use disorder, Opioid addiction prevention and treatment, Pain and addiction, Chronic diseases and substance use disorders, diabetes, pharmacy-based care models and services, medication treatment for opioid use disorder (MOUD), Drug overdose, Polysubstance use and disorders, cannabis, alcohol, tobacco, hallucinogens, stimulants, e-cigarette, SBIRT (substance use Screening, Brief Intervention, Referral to Treatment), EHR-based research and intervention, data science, psychometric analysis (IRT), epidemiology of addictions and comorbidity, behavioral health care integration, health services research (mental health disorders, substance use disorders, chronic diseases), nosology, research design, HIV risk behavior. 

FUNDED Research projects (Principal Investigator [PI], Site PI, or Sub-award PI): 
R03: Substance use/dependence (PI).
R21: Treatment use for alcohol use disorders (PI).
R21: Inhalant use & disorders (PI).
R01: MDMA/hallucinogen use/disorders (PI).
R01: Prescription pain reliever (opioids) misuse and use disorders (PI).
R01: Substance use disorders in adolescents (PI).
R21: CTN Substance use diagnoses & treatment (PI).
R33: CTN Substance use diagnoses & treatment (PI).
R01: Evolution of Psychopathology in the Population (ECA Duke site PI).
R01: Substance use disorders and treatment use among Asian Americans and Pacific Islanders (PI).
UG1: SBIRT in Primary Care (NIDA, PI).
UG1: TAPS Tool, Substance use screening tool validation in primary care (NIDA, PI).
UG1: NIDA CTN Mid-Southern Node (Clinical Trials Network, PI).
UG1: EHR Data Element Study (NIDA, PI).
UG1: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder (NIDA, PI).
PCORI: INSPIRE-Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain (Site PI).
CDC R01: Evaluation of state-mandated acute and post-surgical pain-specific CDC opioid prescribing (Site PI).
Pilot: Measuring Opioid Use Disorders in Secondary Electronic Health Records Data (Carolinas Collaborative Grant: Duke PI).
R21: Developing a prevention model of alcohol use disorder for Pacific Islander young adults (Subaward PI, Investigator).
UG1: Subthreshold Opioid Use Disorder Prevention Trial (NIH HEAL Initiative) (NIDA supplement, CTN-0101, Investigator).
NIDA: A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone through Community Pharmacies for their Stable Methadone Patients (NIDA/FRI: Study PI).
UG1: Integrating pharmacy-based prevention and treatment of opioid and other substance use disorders: A survey of pharmacists and stakeholder (NIH HEAL Initiative, NIDA, PI).
UG1: NorthStar Node of the Clinical Trials Network (NIDA, Site PI).
R34: Intervention Development and Pilot Study to Reduce Untreated Native Hawaiian and Pacific Islander Opioid Use Disorders (Subaward PI, Investigator).
UG1: Optimal Policies to Improve Methadone Maintenance Adherence Longterm (OPTIMMAL Study) (NIDA, Site PI).
R01: Increasing access to opioid use disorder treatment by opening pharmacy-based medication units of opioid treatment programs (NIDA, PI)

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