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| ID | Type | Description | Link |
|---|---|---|---|
| CURE CANN | Other Identifier | Center for the Studies of Addiction |
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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
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Studies show that certain reminders of drug use such as the sight of someone using marijuana, pictures of blunts, particular moments throughout the day, prompt marijuana users to smoke marijuana. We are measuring the brain and behavioral responses of marijuana dependent individuals to these reminders (cues) We will examine brain responses during cue exposure and determine whether these responses are associated with treatment outcome.
We are testing the hypothesis that the medication baclofen reduces brain responses during marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana cues. fMRI is a painless technique that takes special pictures of the brain (or other parts of your body). It does not involve radiation or injections.
Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50% chance of receiving baclofen. Neither the participant nor study personnel will know whether participants are receiving baclofen or placebo. Participants will also receive twice weekly psychosocial treatment with a certified clinician. Twelve weeks of treatment will be followed by a 12 week follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar pill, psychosocial intervention | Placebo Comparator | twice weekly appointments with a certified clinician |
|
| Baclofen, psychosocial intervention | Active Comparator | 20 mg. q.i.d. twice weekly appointments with a certified clinician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine Drug Screen | Change from positive to negative over the 12 weeks of a medication regimen | study weeks 1-12 |
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Inclusion Criteria:
Exclusion Criteria:
Case-by-Case:
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| Name | Affiliation | Role |
|---|---|---|
| Teresa R Franklin, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Center for Studies of Addiction | Philadelphia | Pennsylvania | 19104 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugar Pill, Psychosocial Intervention | twice weekly appointments with a certified clinician Psychosocial Placebo |
| FG001 | Baclofen, Psychosocial Intervention | 20 mg. q.i.d. twice weekly appointments with a certified clinician Baclofen Psychosocial |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugar Pill, Psychosocial Intervention | twice weekly appointments with a certified clinician Psychosocial Placebo |
| BG001 | Baclofen, Psychosocial Intervention | 20 mg. q.i.d. twice weekly appointments with a certified clinician Baclofen Psychosocial |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urine Drug Screen | Change from positive to negative over the 12 weeks of a medication regimen | Posted | Count of Participants | Participants | study weeks 1-12 |
|
|
study weeks 1-12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill, Psychosocial Intervention | twice weekly appointments with a certified clinician Psychosocial Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa R. Franklin, Ph.D., Research Associate Professor of Neuroscience in Psychiatry | University of Pennsylvania | 215-222-3200 | 119 | teresafr@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Psychosocial | Behavioral |
|
| Placebo | Drug |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Baclofen, Psychosocial Intervention | 20 mg. q.i.d. twice weekly appointments with a certified clinician Baclofen Psychosocial | 0 | 8 | 0 | 8 | 4 | 8 |
| Drowsy/Sluggish | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Slowed Cognition | Nervous system disorders | Systematic Assessment |
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| "High" Feeling | Nervous system disorders | Systematic Assessment |
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| Metallic Taste | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal Cramping | Gastrointestinal disorders | Systematic Assessment |
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| Increase in Bowel Movements | Gastrointestinal disorders | Systematic Assessment |
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| Unintended Weight Loss | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |