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Baclofen Effects on Marijuana Dependence

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.
ClinicalTrials.gov Identifier: NCT02011516
Recruitment Status : Completed
First Posted : December 13, 2013
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by (Responsible Party):
Teresa Franklin, University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Marijuana Dependence
Interventions Drug: Baclofen
Behavioral: Psychosocial
Drug: Placebo
Enrollment 47
Recruitment Details

Recruitment Timeframe: 12/2013-10/2014

Potential subjects were recruited via word of mouth, flyers, craigslist and targeted Facebook ads

47 potential subjects were enrolled (consented), 41 were screened, 22 passed screening, 21 baseline scan, 16 randomized, 13 treatment scan, 8 post-tx scan, 10 completed.

Pre-assignment Details All enrolled participants, those that consented to study procedures, participated in a screening process that consisted of a physical and psychological evaluation. Those participants that did not meet our specific inclusion criteria, and/or those that met our exclusion criteria, were not assigned to groups. These individuals were given referrals.
Arm/Group Title Sugar Pill, Psychosocial Intervention Baclofen, Psychosocial Intervention
Hide Arm/Group Description

twice weekly appointments with a certified clinician

Psychosocial

Placebo

20 mg. q.i.d. twice weekly appointments with a certified clinician

Baclofen

Psychosocial

Period Title: Overall Study
Started 8 8
Completed 4 6
Not Completed 4 2
Arm/Group Title Sugar Pill, Psychosocial Intervention Baclofen, Psychosocial Intervention Total
Hide Arm/Group Description

twice weekly appointments with a certified clinician

Psychosocial

Placebo

20 mg. q.i.d. twice weekly appointments with a certified clinician

Baclofen

Psychosocial

Total of all reporting groups
Overall Number of Baseline Participants 8 8 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
8
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 16 participants
Female
4
  50.0%
3
  37.5%
7
  43.8%
Male
4
  50.0%
5
  62.5%
9
  56.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 8 participants 16 participants
8 8 16
1.Primary Outcome
Title Urine Drug Screen
Hide Description Change from positive to negative over the 12 weeks of a medication regimen
Time Frame study weeks 1-12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill, Psychosocial Intervention Baclofen, Psychosocial Intervention
Hide Arm/Group Description:

twice weekly appointments with a certified clinician

Psychosocial

Placebo

20 mg. q.i.d. twice weekly appointments with a certified clinician

Baclofen

Psychosocial

Overall Number of Participants Analyzed 8 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame study weeks 1-12
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Pill, Psychosocial Intervention Baclofen, Psychosocial Intervention
Hide Arm/Group Description

twice weekly appointments with a certified clinician

Psychosocial

Placebo

20 mg. q.i.d. twice weekly appointments with a certified clinician

Baclofen

Psychosocial

All-Cause Mortality
Sugar Pill, Psychosocial Intervention Baclofen, Psychosocial Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Pill, Psychosocial Intervention Baclofen, Psychosocial Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sugar Pill, Psychosocial Intervention Baclofen, Psychosocial Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   4/8 (50.00%)   4/8 (50.00%) 
Gastrointestinal disorders     
Constipation   1/8 (12.50%)  0/8 (0.00%) 
Diarrhea   1/8 (12.50%)  0/8 (0.00%) 
Flatulence   1/8 (12.50%)  0/8 (0.00%) 
Nausea   1/8 (12.50%)  0/8 (0.00%) 
Metallic Taste   1/8 (12.50%)  0/8 (0.00%) 
Abdominal Cramping   0/8 (0.00%)  1/8 (12.50%) 
Increase in Bowel Movements   0/8 (0.00%)  1/8 (12.50%) 
General disorders     
Headache   3/8 (37.50%)  0/8 (0.00%) 
Dry Mouth   1/8 (12.50%)  0/8 (0.00%) 
Metabolism and nutrition disorders     
Unintended Weight Loss   0/8 (0.00%)  1/8 (12.50%) 
Nervous system disorders     
Drowsy/Sluggish   3/8 (37.50%)  1/8 (12.50%) 
Slowed Cognition   1/8 (12.50%)  0/8 (0.00%) 
"High" Feeling   1/8 (12.50%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
Sample size too sample to draw conclusions. No subject was able to provide a negative cannabis urine throughout treatment. A caveat is that cannabis stays in the urine for 6 weeks after final use.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Teresa R. Franklin, Ph.D., Research Associate Professor of Neuroscience in Psychiatry
Organization: University of Pennsylvania
Phone: 215-222-3200 ext 119
Responsible Party: Teresa Franklin, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02011516     History of Changes
Other Study ID Numbers: 818755
CURE CANN ( Other Identifier: Center for the Studies of Addiction )
First Submitted: December 5, 2013
First Posted: December 13, 2013
Results First Submitted: November 23, 2016
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017