Full Text View
Tabular View
No Study Results Posted
Related Studies
Effect of Baclofen on Marijuana Withdrawal and Relapse
This study is currently recruiting participants.
Verified by New York State Psychiatric Institute, November 2006
First Received: September 7, 2006   Last Updated: November 16, 2006   History of Changes
Sponsor: New York State Psychiatric Institute
Collaborator: National Institute on Drug Abuse (NIDA)
Information provided by: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00373295
  Purpose

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.


Condition Intervention Phase
Marijuana Dependence
Drug: Baclofen
Drug: Marijuana
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Effect of Baclofen on Marijuana Withdrawal and Relapse

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: December 2006
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

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373295

Contacts
Contact: Margaret Haney, Ph.D. 212-543-5813

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Principal Investigator: Margaret Haney, Ph.D.            
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
  More Information

No publications provided

Study ID Numbers: 5232
Study First Received: September 7, 2006
Last Updated: November 16, 2006
ClinicalTrials.gov Identifier: NCT00373295     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Baclofen
Marijuana Dependence
Marijuana Withdrawal

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Baclofen
Physiological Effects of Drugs
Disorders of Environmental Origin
Neuromuscular Agents
Marijuana Abuse
Pharmacologic Actions
Mental Disorders
Muscle Relaxants, Central
Therapeutic Uses
GABA Agonists
Substance-Related Disorders
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010