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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA018197 | U.S. NIH Grant/Contract | View source |
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Terminated due to lack of funding.
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Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Modafinil | Active Comparator |
| |
| 2: Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | 400 mg/day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Treatment Effectiveness Scores | Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported. | thrice weekly from week 3 through week 8 |
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Inclusion Criteria:
18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Mancino, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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A total of 20 participants were recruited into the study between 5/26/2009 and 3/30/2010. However, only 9 participants entered the study with 11 dropping out during the consent or intake process. They were recruited from newspaper advertisements and word-of-mouth advertising and who meet the following criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil | Modafinil 400mg orally once daily |
| FG001 | Placebo | Two placebo tablets orally once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil | Modafinil 400mg orally once daily |
| BG001 | Placebo | Two placebo tablets orally once daily |
| 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 | Mean Treatment Effectiveness Scores | Number of negative drug screens for methamphetamine during the study (every negative drug screen obtained is counted as 1 negative drug screen)divided by the total possible number of drug screens during the 6 week post residential phase of trial(participants provided 3 drug screens per week so the expected number of drug screens total is 18.This does include week 8. Missing drug screens are counted as positive.# negative drug screens/18. Minimum score is 0 and maximum score is 1. The higher the score the better the outcome. The mean of the individual treatment effectiveness scores is reported. | Participants that completed the 2 week residential treatment and entered the outpatient phase with intent to treat and missing urines treated as positive urines. | Posted | Mean | Standard Deviation | scores on a scale | thrice weekly from week 3 through 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 | Modafinil | Modafinil 400mg orally once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
Early termination leading to small numbers of subjects analyzed. Small number of completers leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J. Mancino, M.D. | University of Arkansas for Medical Sciences | 501-526-8442 | mjmancino@uams.edu |
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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 |
inactive substance |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants received 2 capsules placebo orally daily
| OG001 | Modafinil | Modafinil 400mg orally daily |
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | Placebo | Two placebo tablets orally once daily | 0 | 3 | 2 | 3 |
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Weight loss | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |