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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA026758-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a clinical study to evaluate the efficacy of the medication gabapentin in treating persons with cannabis dependence.
This is a 12-week, double blind, placebo controlled study to evaluate the efficacy of gabapentin in treating outpatients with cannabis dependence. After an initial phone screen, a comprehensive screening visit is scheduled to determine eligibility. Upon enrollment, counseling, medication dispensation and research assessments occur 1 time per week for 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin 1200mg/day | Experimental | 1200mg/day of gabapentin for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. |
|
| Placebo | Placebo Comparator | 1200mg/day of placebo for 12 weeks given in conjunction with 12 weeks of manual-guided behavioral counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gabapentin 1200mg/day | Drug | gabapentin 1200mg/day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara J Mason, Ph.D. | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute | La Jolla | California | 92037 | United States |
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| Label | URL |
|---|---|
| Study Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin 1200mg/Day | 1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling. |
| FG001 | Placebo | Matched placebo given in conjunction with standardized manual-guided behavioral counseling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin 1200mg/Day | 1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling. |
| BG001 | Placebo | Matched placebo given in conjunction with standardized manual-guided behavioral counseling. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period | Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR). | Two participants in the gabapentin group and one in the placebo group were lost to follow up after randomization and did not submit any UDS for testing while on study. Two participants in the placebo group withdrew from the study at the week 1 visit, and thus did not submit any UDS for testing while on study. | Posted | Mean | Standard Deviation | percentage of negative UDS | 12 weeks |
|
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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 | Gabapentin 1200mg/Day | 1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy to arthropod sting | Immune system disorders | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Mason | The Scripps Research Institute | (858) 784-7324 | mason@scripps.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo | Drug | 1200mg/day of placebo for 12 weeks |
|
| Manual-guided behavioral counseling | Behavioral | Standardized manual-guided behavioral counseling performed 1 time per week for 12 weeks in conjunction with study drug or placebo. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Gabapentin 1200mg/Day |
1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling. |
| OG001 | Placebo | Matched placebo given in conjunction with standardized manual-guided behavioral counseling. |
|
|
| 0 |
| 150 |
| 40 |
| 75 |
| EG001 | Placebo | Matched placebo given in conjunction with standardized manual-guided behavioral counseling. | 1 | 150 | 50 | 75 |
| Skin infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |