Effect of Baclofen on Marijuana Withdrawal and Relapse

NCT00373295 | Completed Phase 2 Results

• 2 other identifiers: 52325P50DA009236
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if baclofen dose-dependently decreases marijuana's direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse.

Conditions

Marijuana Dependence

Keywords

Baclofen; Marijuana Dependence; Marijuana Withdrawal

Outcome Measures

Primary Outcomes (1)

• Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase

  This is a measure of marijuana self-administration and relapse since each initial puff costs $7 and is a burden to overcome just to smoke. Over each 3 day period, the puffs chosen by each participant is averaged for a single value.

  Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)

Study Arms (6)

Baclofen 60 mg, Placebo, Baclofen 90 mg

EXPERIMENTAL

Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.

Drug: Baclofen; Drug: Marijuana; Drug: Placebo

Baclofen 90 mg, Placebo, Baclofen 60 mg

EXPERIMENTAL

Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.

Drug: Baclofen; Drug: Marijuana; Drug: Placebo

Baclofen 60 mg, Baclofen 90 mg, Placebo

EXPERIMENTAL

Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.

Drug: Baclofen; Drug: Marijuana; Drug: Placebo

Baclofen 90 mg, Baclofen 60 mg, Placebo

EXPERIMENTAL

Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.

Drug: Baclofen; Drug: Marijuana; Drug: Placebo

Placebo, Baclofen 90 mg, Baclofen 60 mg

EXPERIMENTAL

Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.

Drug: Baclofen; Drug: Marijuana; Drug: Placebo

Placebo, Baclofen 60 mg, Baclofen 90 mg

EXPERIMENTAL

Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200). Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.

Drug: Baclofen; Drug: Marijuana; Drug: Placebo

Interventions

Baclofen DRUG

Baclofen (60mg/day or 90 mg/day): Packaged medication in size 00 opaque capsules with riboflavin filler. Study capsules (0, 20, 30mg) were administered 3 times per day (0900, 1530, 2200).

Also known as: Lioresal

Baclofen 60 mg, Baclofen 90 mg, Placebo; Baclofen 60 mg, Placebo, Baclofen 90 mg; Baclofen 90 mg, Baclofen 60 mg, Placebo; Baclofen 90 mg, Placebo, Baclofen 60 mg; Placebo, Baclofen 60 mg, Baclofen 90 mg; Placebo, Baclofen 90 mg, Baclofen 60 mg

Marijuana DRUG

Marijuana: Participants each received a single marijuana cigarette (provided by the National Institute on Drug Abuse) at each smoking occasion. Marijuana cigarettes were stored frozen in an airtight container and humidified at room temperature for 24 h prior to use.

Also known as: cannabis

Baclofen 60 mg, Baclofen 90 mg, Placebo; Baclofen 60 mg, Placebo, Baclofen 90 mg; Baclofen 90 mg, Baclofen 60 mg, Placebo; Baclofen 90 mg, Placebo, Baclofen 60 mg; Placebo, Baclofen 60 mg, Baclofen 90 mg; Placebo, Baclofen 90 mg, Baclofen 60 mg

Placebo DRUG

Baclofen 60 mg, Baclofen 90 mg, Placebo; Baclofen 60 mg, Placebo, Baclofen 90 mg; Baclofen 90 mg, Baclofen 60 mg, Placebo; Baclofen 90 mg, Placebo, Baclofen 60 mg; Placebo, Baclofen 60 mg, Baclofen 90 mg; Placebo, Baclofen 90 mg, Baclofen 60 mg

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for the past 4 weeks
• Able to perform study procedures
• years of age
• Women practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

You may not qualify if:

• Current, repeated illicit drug use (other than marijuana)
• Presence of significant medical illness(e.g., diabetes, cardiovascular disease, hypertension, examination, laboratory clinically significant laboratory abnormalities)
• History of heart disease
• Request for drug treatment
• Current parole or probation
• Pregnancy or current lactation
• Recent history of significant violent behavior
• Major current Axis I psychopathology(e.g., major depressive disorder, bipolar disorder, suicide risk, schizophrenia)
• Current use of any prescription or over-the-counter medication

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

Related Publications (1)

• Haney M, Hart CL, Vosburg SK, Comer SD, Reed SC, Cooper ZD, Foltin RW. Effects of baclofen and mirtazapine on a laboratory model of marijuana withdrawal and relapse. Psychopharmacology (Berl). 2010 Aug;211(2):233-44. doi: 10.1007/s00213-010-1888-6. Epub 2010 Jun 3.

  PMID: 20521030 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Baclofen; nabiximols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Dr. Margaret Haney
• Organization: New York State Psychiatric Institute

reslabsurc@gmail.com

646-774-6129

Study Officials

• Margaret Haney, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2010
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Locations

US (1)