Effect of Baclofen on Marijuana Withdrawal and Relapse
Information source: New York State Psychiatric Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Marijuana Dependence
Intervention: Baclofen (Drug); Marijuana (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s):
Margaret Haney, Ph.D., Principal Investigator, Affiliation: New York State Psychiatric Institute
Overall contact:
Margaret Haney, Ph.D., Phone: 212-543-5813
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.
Clinical Details
Official title: Effect of Baclofen on Marijuana Withdrawal and Relapse
Study design: Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Detailed 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.
Eligibility
Minimum age: 21 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Margaret Haney, Ph.D., Phone: 212-543-5813
New York State Psychiatric Institute, New York, New York 10032, United States; Recruiting
Margaret Haney, Ph.D., Principal Investigator
Additional Information
Starting date: May 2006
Ending date: December 2006
Last updated: November 16, 2006
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