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Effect of Baclofen on Marijuana Withdrawal and Relapse

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00373295
First received: September 7, 2006
Last updated: February 4, 2013
Last verified: February 2013

September 7, 2006
February 4, 2013
May 2006
January 2008   (final data collection date for primary outcome measure)
marijuana self-administration [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00373295 on ClinicalTrials.gov Archive Site
marijuana withdrawal symptoms [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Not Provided
psychomotor task performance [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Not Provided
 
Effect of Baclofen on Marijuana Withdrawal and Relapse
Effect of Baclofen on Marijuana Withdrawal and Relapse

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.

Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence. The objective of this study is to investigate the interaction between marijuana and the potential treatment medication, baclofen, with the direct goal of using this information to improve marijuana treatment outcome. GABAB agonists such as baclofen have been shown to attenuate the self-administration of cocaine, heroin, alcohol and nicotine (see Cousins et al., 2002; Haney et al., 2006). Baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers (Akhondzadeh et al., 2000; Addolorato et al., 2000). 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 in our laboratory model. For the purposes of this model, relapse is defined as a return to marijuana use after a period of abstinence. The study will utilize an inpatient/outpatient, counter-balanced design, with each participant maintained on each of three medication conditions for 16 days: placebo and baclofen (60, 90 mg/day). Participants will begin taking capsules during the outpatient phase so that the dose can be incremented up to the maintenance dose prior to the first inpatient day. Further, clinical studies have shown that baclofen is most effective at decreasing cocaine's effects when administered for several weeks. During the inpatient study phases, participants will have the opportunity to self-administer placebo or active marijuana 6 times per day. This study will provide important information of the effect of baclofen as a potential treatment medication for marijuana dependence.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Marijuana Dependence
  • Drug: Baclofen
    measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
    Other Name: Lioresal
  • Drug: Marijuana
    measured baclofen's effects on marijuana withdrawal and relapse
    Other Name: cannabis
Experimental: baclofen, marijuana
baclofen (60, 90 mg)/day
Interventions:
  • Drug: Baclofen
  • Drug: Marijuana
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
January 2010
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for the past 4 weeks
  • Able to perform study procedures
  • 21-45 years of age
  • Women practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

Exclusion Criteria:

  • 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
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373295
5232, 5P50DA009236
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
New York State Psychiatric Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP