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| ID | Type | Description | Link |
|---|---|---|---|
| DA023548 | Other Grant/Funding Number | NIDA |
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This protocol is a 2-group double-blind placebo-controlled outpatient study investigating lisdexamfetamine for treatment of cocaine dependence. The investigators plan to enroll 100 subjects in a 14-week trial. The primary objectives will determine changes in cocaine use and secondary objectives will be cocaine craving and impulsivity.
This 2-group, double-blind, placebo-controlled, 14-week study (N=100) will investigate the efficacy of cognitive behavioral therapy plus lisdexamfetamine vs. placebo to treat cocaine dependence. We hypothesize that lisdexamfetamine will reduce cocaine use (primary outcome), as well as cocaine craving and impulsivity (secondary outcomes) vs. placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lisdexamfetamine/Behavior Therapy | Active Comparator | lisdexamfetamine 70mg/day plus Behavior Therapy |
|
| placebo | Placebo Comparator | Placebo Comparator once per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lisdexamfetamine/Behavior Therapy | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine-positive Urine Results | At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL. | 14 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Craving | On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being "very little" to 100 being "very much". | 14 Weeks |
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Inclusion Criteria:
Eligible participants must:
Exclusion Criteria:
Exclusion criteria include:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Mooney, Ph.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Research Center/Fairview University Psychiatry Dept | Minneapolis | Minnesota | 55454 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lisdexamfetamine | lisdexamfetamine 70mg/day lisdexamfetamine cognitive behavioral therapy |
| FG001 | Placebo | Placebo Comparator once per day placebo cognitive behavioral therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lisdexamfetamine | lisdexamfetamine 70mg/day lisdexamfetamine cognitive behavioral therapy |
| BG001 | Placebo | Placebo Comparator once per day placebo cognitive behavioral therapy |
| 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-positive Urine Results | At each visit, subjects provided urine samples, which were analyzed for benzoylecgonine (BE; a cocaine metabolite). BE was assessed semi-quantitatively using the PROFILE® -V MEDTOXScan® Drugs of Abuse Test System, with cocaine positive tests equaling or exceeding 150 ng/mL. | Posted | Mean | Standard Deviation | percentage of BE urine tests | 14 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 | Lisdexamfetamine/Behavior Therapy | lisdexamfetamine 70mg/day plus Behavior Therapy lisdexamfetamine/Behavior Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | Systematic Assessment | A patient was hospitalized for chest pain and diagnosed with angina that was possibly related to the study drug. He did not continue in the study. He was assigned to the LDX condition. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc Mooney | University of Minnesota | 6129916875 | moon0078@umn.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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| Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Drug Craving | On a weekly basis, patients completed measures of cocaine craving using the Minnesota Cocaine Craving Scale. The Minnesota Cocaine Craving Scale is a self report questionnaire and ranges from 0 to 100, 0 being "very little" to 100 being "very much". | Posted | Mean | Standard Error | units on a scale | 14 Weeks |
|
|
|
| 1 |
| 22 |
| 0 |
| 22 |
| EG001 | Placebo | Placebo Comparator once per day placebo | 1 | 21 | 0 | 21 |
|
| Psychosis | Psychiatric disorders | Systematic Assessment | A subject was hospitalized with psychosis (assigned to the placebo condition). She had apparently binged on cocaine prior to her psychotic episode. In addition she failed to reveal to study staff that she was diagnosed with schizoaffective disorder. |
|
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| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |