Dronabinol Naltrexone Treatment for Opioid Dependence

NCT01024335 | Completed Phase 2 Results DMC

• 3 other identifiers: #5962 DA027124R01DA027124DPMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.

Conditions

Opioid Dependence

Keywords

opioid dependence; naltrexone; vivitrol; dronabinol; marinol

Outcome Measures

Primary Outcomes (2)

• Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) .

  The Subjective Opiate Withdrawal Scale is a self-administered 16 scale containing 16 symptoms ranging in severity from 0 (not at all) to 4 (extremely). The SOWS total score is the sum of 16 items, ranging from 0 (no opiate withdrawal ) to 64 ( severe opiate withdrawal). Values from multiple assessments during the 8-week outpatient phase were averaged.

  3x/week during 8 weeks of the trial or study participation

• Retention

  Of those participants randomized to the naltrexone and dronabinol arm, the number that completed all 8 weeks of treatment.

  retention over 8 weeks.

Study Arms (2)

Naltrexone and placebo

ACTIVE COMPARATOR

A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.

Drug: Naltrexone and placebo

Naltrexone and dronabinol

EXPERIMENTAL

A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.

Drug: injectable naltrexone and dronabinol

Interventions

injectable naltrexone and dronabinol DRUG

Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.

Naltrexone and dronabinol

Naltrexone and placebo DRUG

Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.

Naltrexone and placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Adult, aged 18-60.
• \. Meets Diagnostic and Statistical Manual -IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
• \. Have a history of marijuana use (more than 30 occasions lifetime)
• \. Voluntarily seeking treatment for opioid dependence
• \. In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.
• \. Able to give informed consent.

You may not qualify if:

• \. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal.
• \. Patients meeting current criteria for cannabis abuse or dependence, and those who used cannabis in the week prior to study entry as documented by the positive toxicology
• \. Significant current suicidal risk or 1 or more suicide attempts within the past year
• \. History of accidental drug overdose in the last three years defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
• \. Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory method of birth control
• \. Active psychiatric disorder which might interfere with participation or make participation hazardous, including Diagnostic and Statistical Manual -IV organic mental disorder, psychotic disorder, or bipolar disorder with mania
• \. History of allergic reaction, adverse reaction, or sensitivity to any study medication.
• \. Acute hepatitis with serum glutamic-oxaloacetic transaminase or serum glutamic-pyruvic transaminase \> 3 times the upper end of the laboratory normal range (chronic hepatitis is acceptable as we have found naltrexone treatment well tolerate and safe among patients with chronic hepatitis)
• \. Currently prescribed or regularly taking opiates for chronic pain or medical illness.
• \. Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (\>30 mg per week).
• \. Current participation in another intensive psychotherapy or substance abuse treatment program or participation in another treatment study.
• \. Concurrent treatment with psychotropic medications

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Dronabinol; Naltrexone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Adam Bisaga
• Organization: NYS Psychiatric Institute

amb107@columbia.edu

646-774-6155

Study Officials

• Adam Bisaga, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 18, 2018
• Results First Posted: September 5, 2014

Record last verified: 2018-05

Locations

US (1)