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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA030988-04S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.
Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: aprepitant 125 mg/day | Active Comparator | 125 mg aprepitant daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
|
| Placebo 125mg/d | Placebo Comparator | Matched placebo pill given daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant | Drug | 125 mg daily for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 | Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value). | Week 0 and Week 8 |
| Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol. | Week 0 and Week 8 |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant: 125mg/Day | 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
| FG001 | Matched Placebo | Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant: 125mg/Day | 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
| BG001 | Matched Placebo | Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of 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 | Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 | Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value). | Posted | Mean | Standard Deviation | ng/mg | Week 0 and Week 8 |
|
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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 | Aprepitant: 125mg/Day | 125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Faeces discoloured | Gastrointestinal disorders | MedDRA (19.0) | 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 |
| D000437 | Alcoholism |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo daily for 8 weeks. |
|
| Manual-guided behavioral counseling | Behavioral | Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Matched Placebo | Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. |
|
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| Primary | Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8 | Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol. | Posted | Mean | Standard Deviation | drinks/week | Week 0 and Week 8 |
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Matched Placebo | Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling. | 0 | 10 | 6 | 10 |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
|
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