Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial.

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2009-04

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Abstract

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.

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10.1111/j.1369-1600.2008.00119.x

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Mannelli, Paolo, Ashwin A Patkar, Kathi Peindl, David A Gorelick, Li-Tzy Wu and Edward Gottheil (2009). Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial. Addiction biology, 14(2). pp. 204–213. 10.1111/j.1369-1600.2008.00119.x Retrieved from https://hdl.handle.net/10161/29083.

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Scholars@Duke

Mannelli

Paolo Mannelli

Professor of Psychiatry and Behavioral Sciences
Wu

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)
R01: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults (Subaward PI, Investigator).
R01: Understanding the short- and long-term effects of the COVID-19 pandemic on the overdose crisis (Subaward PI, Investigator).



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