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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009262-12 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.
This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 60 mg dose of d-amphetamine; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-Amphetamine 60mg + Therapy | Experimental | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
|
| Modafinil 400mg + Therapy | Experimental | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
|
| Modafinil 200mg + D-Amphetamine 30mg + Therapy | Experimental | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-Amphetamine 30mg | Drug |
| ||
| D-Amphetamine 60mg |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment | 16 weeks | |
| Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment | 16 weeks | |
| Retention as Indicated by the Number of Participants Who Remained in the Study | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report | 16 weeks | |
| Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy M. Schmitz, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22969732 | Result | Schmitz JM, Rathnayaka N, Green CE, Moeller FG, Dougherty AE, Grabowski J. Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation. Front Psychiatry. 2012 Aug 30;3:77. doi: 10.3389/fpsyt.2012.00077. eCollection 2012. |
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| ID | Title | Description |
|---|---|---|
| FG000 | D-Amphetamine 60mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| FG001 | Modafinil 400mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| FG002 | Modafinil 200mg + D-Amphetamine 30mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| FG003 | Placebo + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | D-Amphetamine 60mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| 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 Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment | All participants who received the first dose of study medication were included in this analysis. | Posted | Mean | Standard Deviation | number of cocaine negative urines | 16 weeks |
|
16 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 | D-Amphetamine 60mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine SR (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Systematic Assessment |
High attrition; Pill-taking burden (3 capsules daily) contributed to medication non-compliance; Small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Joy M. Schmitz | The University of Texas Health Science Center at Houston | (713) 486-2867 | Joy.M.Schmitz@uth.tmc.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 |
|---|---|
| D003913 | Dextroamphetamine |
| D000077408 | Modafinil |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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|
| Placebo + Therapy | Placebo Comparator | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
|
| Drug |
|
| Modafinil 200mg | Drug |
|
| Modafinil 400mg | Drug |
|
| Therapy | Behavioral | Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
|
| Placebo | Drug |
|
| BG001 | Modafinil 400mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| BG002 | Modafinil 200mg + D-Amphetamine 30mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| BG003 | Placebo + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Modafinil 400mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| OG002 | Modafinil 200mg + D-Amphetamine 30mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| OG003 | Placebo + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
|
|
| Primary | Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment | Posted | Number | participants | 16 weeks |
|
|
|
| Primary | Retention as Indicated by the Number of Participants Who Remained in the Study | Posted | Number | participants | 16 weeks |
|
|
|
| Secondary | Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report | Posted | Number | percentage of pills taken | 16 weeks |
|
|
|
| Secondary | Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples | Posted | Number | % of riboflavin-positive urine samples | 16 weeks |
|
|
|
| 0 |
| 22 |
| 1 |
| 22 |
| EG001 | Modafinil 400mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. | 0 | 20 | 3 | 20 |
| EG002 | Modafinil 200mg + D-Amphetamine 30mg + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. | 0 | 15 | 2 | 15 |
| EG003 | Placebo + Therapy | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Manual-based,cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. | 0 | 16 | 0 | 16 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Migraine | Vascular disorders | Systematic Assessment |
|
| Change in electrocardiogram (EKG) | Cardiac disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| D000588 |
| Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |