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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
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The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil | Active Comparator | Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks |
|
| Placebo | Placebo Comparator | Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | 200 mg or 400 mg /daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence (Week 1 - 12) | Number of participant who abstained from methamphetamine from weeks 1 through 12 | Weeks 1 - 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Craving | Number of subjects with 21 or more consecutive days of abstinence | 21 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elkashef, M.D. | National Institute on Drug Abuse (NIDA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Bay Treatment Center | San Diego | California | 92105 | United States | ||
| Matrix Institute on Addictions |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21840138 | Result | Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):135-41. doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil | Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily |
| FG001 | Placebo | Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil | Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily |
| BG001 | Placebo | Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily |
| 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 | Abstinence (Week 1 - 12) | Number of participant who abstained from methamphetamine from weeks 1 through 12 | Posted | Count of Participants | Participants | 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 | Modafinil | Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil: 200 mg or 400 mg /daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liza Zeinert | National Institutes of Health | 301-443-1138 | liza.zeinert@nih.gov |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Placebo / daily |
|
| Tarzana |
| California |
| 91356 |
| United States |
| Torrance Site | Torrance | California | 90502 | United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80220 | United States |
| John A. Burns School of Medicine | Honolulu | Hawaii | 96813 | United States |
| Powell Chemical Dependency Center | Des Moines | Iowa | 50316 | United States |
| START Research and Treatment | Kansas City | Missouri | 64131 | United States |
| Salt Lake City VA Medical Center | Salt Lake City | Utah | 84148 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Reduction of Craving | Number of subjects with 21 or more consecutive days of abstinence | Posted | Count of Participants | Participants | 21 days |
|
|
|
| 0 |
| 142 |
| 128 |
| 142 |
| EG001 | Placebo | Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Placebo: Placebo / daily | 5 | 68 | 54 | 68 |
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| Celluitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Compartment syndrome left forearm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |