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Effect of Baclofen on Marijuana Withdrawal and Relapse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373295
First Posted: September 8, 2006
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: October 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Marijuana Dependence
Interventions: Drug: Baclofen
Drug: Marijuana
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
13 participants were enrolled, but 10 participants were randomized. Three volunteers (1 female, 2 male) dropped out of the study during the marijuana abstinence phase (two were on baclofen and one was on placebo).

Reporting Groups
  Description
Baclofen 60 mg, Placebo, Baclofen 90 mg participants received baclofen (60 mg/day) for 8 days, followed by placebo for 8 days, then baclofen (90mg/day) for 8 days.
Baclofen 90 mg, Placebo, Baclofen 60 mg participants received baclofen (90mg/day) for 8 days, followed by placebo for 8 days, then baclofen (60mg/day) for 8 days.
Baclofen 60 mg, Baclofen 90 mg, Placebo participants received baclofen (60mg/day) for 8 days, followed by baclofen (90mg/day) for 8 days, then placebo for 8 days.
Baclofen 90 mg, Baclofen 60 mg, Placebo participants received baclofen (90mg/day) for 8 days, followed by baclofen (60mg/day) for 8 days, and then placebo for 8 days.
Placebo, Baclofen 90 mg, Baclofen 60 mg participants received placebo for 8 days, followed by baclofen (90mg/day) for 8 days, then baclofen (60mg/day) for 8 days.
Placebo, Baclofen 60 mg, Baclofen 90 mg participants received placebo for 8 days, followed by baclofen (60mg/day) for 8 days, then baclofen (90mg/day) for 8 days.

Participant Flow for 3 periods

Period 1:   Intervention 1 (8 Days)
    Baclofen 60 mg, Placebo, Baclofen 90 mg   Baclofen 90 mg, Placebo, Baclofen 60 mg   Baclofen 60 mg, Baclofen 90 mg, Placebo   Baclofen 90 mg, Baclofen 60 mg, Placebo   Placebo, Baclofen 90 mg, Baclofen 60 mg   Placebo, Baclofen 60 mg, Baclofen 90 mg
STARTED   2   3   1   2   3   2 
COMPLETED   2   1   1   2   2   2 
NOT COMPLETED   0   2   0   0   1   0 
Withdrawal by Subject                0                2                0                0                1                0 

Period 2:   Intervention 2 (8 Days)
    Baclofen 60 mg, Placebo, Baclofen 90 mg   Baclofen 90 mg, Placebo, Baclofen 60 mg   Baclofen 60 mg, Baclofen 90 mg, Placebo   Baclofen 90 mg, Baclofen 60 mg, Placebo   Placebo, Baclofen 90 mg, Baclofen 60 mg   Placebo, Baclofen 60 mg, Baclofen 90 mg
STARTED   2   1   1   2   2   2 
COMPLETED   2   1   1   2   2   2 
NOT COMPLETED   0   0   0   0   0   0 

Period 3:   Intervention 3 (8 Days)
    Baclofen 60 mg, Placebo, Baclofen 90 mg   Baclofen 90 mg, Placebo, Baclofen 60 mg   Baclofen 60 mg, Baclofen 90 mg, Placebo   Baclofen 90 mg, Baclofen 60 mg, Placebo   Placebo, Baclofen 90 mg, Baclofen 60 mg   Placebo, Baclofen 60 mg, Baclofen 90 mg
STARTED   2   1   1   2   2   2 
COMPLETED   2   1   1   2   2   2 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Study Participants Participants received placebo, baclofen (60mg) and baclofen (90mg) and smoked Marijuana (5.3% THC).

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1  10.0% 
Male      9  90.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   10 


  Outcome Measures

1.  Primary:   Measure of Relapse: Change in Money Spent Between Baseline and Relapse Phase   [ Time Frame: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Margaret Haney
Organization: New York State Psychiatric Institute
phone: 646-774-6129
e-mail: reslabsurc@gmail.com


Publications:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00373295     History of Changes
Other Study ID Numbers: 5232
5P50DA009236 ( U.S. NIH Grant/Contract )
First Submitted: September 7, 2006
First Posted: September 8, 2006
Results First Submitted: October 20, 2016
Results First Posted: May 10, 2017
Last Update Posted: May 10, 2017