Effect of Baclofen on Marijuana Withdrawal and Relapse

Marijuana Dependence Clinical Trial

Official title:

Effect of Baclofen on Marijuana Withdrawal and Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373295
• Other study ID #: 5232
• Secondary ID: 5P50DA009236
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2006
• Last updated: February 4, 2013
• Start date: May 2006
• Est. completion date: January 2010

Study information

• Verified date: February 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2010
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Drug:
• Baclofen
measured baclofen's effects on marijuana withdrawal and relapse relative to placebo
• Marijuana
measured baclofen's effects on marijuana withdrawal and relapse

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	psychomotor task performance		3 days	No
Primary	marijuana self-administration		4 days	No
Secondary	marijuana withdrawal symptoms		3 days	No