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Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Modafinil 400 mg daily |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | 400 mg daily for four weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Methamphetamine-positive Urine Drug Screens | Percentage of participants with at least one biweekly urine drug screen positive for methamphetamine (4 weeks active treatment phase + medication-free safety visit at week 5) | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in California Verbal Learning Test From Baseline to Study Endpoint | Mean percent change in T scores (average total score of 6 trials) from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes. | Study baseline to study endpoint (Week 5) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan K Tolliver, MD, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Health Services of Pickens County | Pickens | South Carolina | 29671 | United States |
The Enrollment number in the Protocol Section has been corrected (n=40) to appropriately match the number of participants listed in the Results Participant Flow section. The previous Protocol section incorrectly included a cohort (n=31) of healthy control subjects who underwent cognitive testing but did not participate in the modafinil trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil | Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks |
| FG001 | Placebo | Placebo Placebo: Placebo 2 tablets daily for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil | Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks |
| BG001 | Placebo | Placebo Placebo: Placebo 2 tablets daily for 4 weeks |
| 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 Participants With Methamphetamine-positive Urine Drug Screens | Percentage of participants with at least one biweekly urine drug screen positive for methamphetamine (4 weeks active treatment phase + medication-free safety visit at week 5) | Posted | Number | Percentage of participants | 5 weeks |
|
Five weeks: Four weeks of active study medication, safety visit one week after medication washout
Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 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 | Modafinil | Modafinil: 400 mg daily for four weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
Limited sample size (n=40, n=20 in each group), relatively low retention (55% overall; 45% in modafinil group, 65% in placebo group)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan K. Tolliver, MD PhD | Medical University of South Carolina | 843-792-4869 | tollive@musc.edu |
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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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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| Placebo | Drug | Placebo 2 tablets daily for 4 weeks |
|
| Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint |
Mean percent change in T scores from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes. |
| 5 Weeks |
| Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint | Mean percent change of T scores from baseline to study endpoint (Week 5) in study completers. Min T score = 0, max T score = 100. Higher scores, greater (more positive) percent change indicate better outcomes. | 5 weeks |
| Score on the Wisconsin Card Sort Test | Scores (T scores) on the Wisconsin Card Sort Test (total errors) at study endpoint (Week 5) in study completers, adjusted for age and education; min=0, max=100, higher numbers indicate better outcomes. | 5 weeks |
| Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint | Percent change of T scores from baseline to study endpoint (Week 5) in study completers; T score min=0, max=100; higher scores (more positive change) indicate better outcome. | 5 weeks |
| Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint | Percent change in scores (T scores) on the Shipley Abstract subscale from baseline to study endpoint (Week 5) in study completers; T scores min=0, max=100; larger positive values indicate better outcome. | 5 weeks |
| Percentage Change in Beck Depression Inventory Scores | Percent change in BDI score from baseline to study endpoint in study completers; range =-100% to 100%, larger (more negative) change indicates better outcome. | 5 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percent Change in California Verbal Learning Test From Baseline to Study Endpoint | Mean percent change in T scores (average total score of 6 trials) from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes. | Posted | Mean | Standard Deviation | Percent change, baseline-study endpoint | Study baseline to study endpoint (Week 5) |
|
|
|
| Secondary | Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint | Mean percent change in T scores from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes. | Posted | Mean | Standard Deviation | Percent change, baseline-study endpoint | 5 Weeks |
|
|
|
| Secondary | Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint | Mean percent change of T scores from baseline to study endpoint (Week 5) in study completers. Min T score = 0, max T score = 100. Higher scores, greater (more positive) percent change indicate better outcomes. | Posted | Mean | Standard Deviation | Percent change, baseline-study endpoint | 5 weeks |
|
|
|
| Secondary | Score on the Wisconsin Card Sort Test | Scores (T scores) on the Wisconsin Card Sort Test (total errors) at study endpoint (Week 5) in study completers, adjusted for age and education; min=0, max=100, higher numbers indicate better outcomes. | Note: Total number of study completers = 22 (9 in Modafinil group and 13 in Placebo group). The Wisconsin Card Sort Test was able to be completed in only 19 of 22 study completers (8 participants assigned to Modafinil and 11 participants assigned to Placebo). | Posted | Mean | Standard Deviation | T scores at study endpoint | 5 weeks |
|
|
|
| Secondary | Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint | Percent change of T scores from baseline to study endpoint (Week 5) in study completers; T score min=0, max=100; higher scores (more positive change) indicate better outcome. | Posted | Mean | Standard Deviation | Percent change, baseline-study endpoint | 5 weeks |
|
|
|
| Secondary | Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint | Percent change in scores (T scores) on the Shipley Abstract subscale from baseline to study endpoint (Week 5) in study completers; T scores min=0, max=100; larger positive values indicate better outcome. | Posted | Mean | Standard Deviation | T scores, percent change | 5 weeks |
|
|
|
| Secondary | Percentage Change in Beck Depression Inventory Scores | Percent change in BDI score from baseline to study endpoint in study completers; range =-100% to 100%, larger (more negative) change indicates better outcome. | Note: Total number of study completers = 22 (9 in Modafinil group and 13 in Placebo group). Beck Depression Inventory Scores at study endpoint were obtained in only 20 of 22 study completers (9 participants assigned to Modafinil and 11 participants assigned to Placebo). | Posted | Mean | Standard Deviation | Percent change | 5 weeks |
|
|
|
| 20 |
| 0 |
| 20 |
| 16 |
| 20 |
| EG001 | Placebo | Placebo: 2 tablets daily for four weeks | 0 | 20 | 0 | 20 | 14 | 20 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Common cold symptoms | General disorders | Systematic Assessment |
|
| Hypersomnia | General disorders | Systematic Assessment |
|
| Abdominal cramps | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased appetite | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry mouth / thirst | General disorders | Systematic Assessment |
|
| Ear / sinus infection | Infections and infestations | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Elevated blood pressure | General disorders | Systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |