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| ID | Type | Description | Link |
|---|---|---|---|
| DA011744-08 |
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The medication modafinil has been shown to reduce cocaine use in some cocaine users. The investigators have shown that modafinil taken in the morning improves sleep in chronic cocaine users. The investigators hypothesize that the beneficial effects of modafinil in reducing cocaine use may be related to specific effects modafinil has on sleep. This study will measure sleep and cocaine use in cocaine dependent persons who are trying to stop using cocaine, and will test the connection between modafinil's effects on sleep and cocaine use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Modafinil 400mg PO QDaily following up-titration for ~8weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| %Cocaine Free Urines | 3x/week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in N3 (Slow-wave) Sleep Time | change from week 1 to week 2 of inpatient treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Morgan, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24315572 | Derived | Angarita GA, Canavan SV, Forselius E, Bessette A, Pittman B, Morgan PT. Abstinence-related changes in sleep during treatment for cocaine dependence. Drug Alcohol Depend. 2014 Jan 1;134:343-347. doi: 10.1016/j.drugalcdep.2013.11.007. Epub 2013 Nov 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil | Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence |
| FG001 | Placebo | Placebo: Placebo medication Qdaily for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil | Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence |
| BG001 | Placebo |
| 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 | %Cocaine Free Urines | Posted | Mean | Standard Error | percent | 3x/week |
|
|
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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 | Modafinil | Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Morgan | Yale University | 203-974-7560 | peter.morgan@yale.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Cognitive Behavioral Therapy |
| Behavioral |
Once weekly cognitive behavioral therapy for cocaine dependence |
|
Placebo: Placebo medication Qdaily for ~8weeks
Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Change in N3 (Slow-wave) Sleep Time | Posted | Mean | Standard Error | minutes | change from week 1 to week 2 of inpatient treatment |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | Placebo: Placebo medication Qdaily for ~8weeks Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence | 0 | 27 | 0 | 27 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |