Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA023652-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.
Specific Aim 1: To determine the efficacy of ER-MAS in promoting cocaine abstinence and ADHD improvement among comorbid ADHD and cocaine-dependent patients.
Primary Hypothesis: benzoylecgonine positive urine screens will decrease with greatest to least reductions from 80mg>60mg>PBO (placebo).
Hypothesis 2: ADHD-Rating Scale will decrease with greatest to least reductions from 80mg>60mg>PBO.
Specific Aim 2: To determine the effect of ER-MAS on improving general functioning and impulsivity among comorbid ADHD and cocaine-dependent patients.
Hypothesis 4: There will be greater improved CGI (clinical global impression scale) scores in participants receiving d-AMPH (d-amphetamine) compared to PBO.
Hypothesis 5: ER-MAS will decrease impulsivity as measured by several self-report (Barratts Impulsivity Scale) and behavioral measures (Card Sort, IMT (immediate memory task), DMT (delayed memory task), BART) compared to PBO.
This 14-week, three arm (two medication doses versus PBO), prospective, parallel groups, randomized PBO-controlled trial with a lead-in as well as medication run-up and run down weeks, will provide clear data on efficacy and safety for definitive Phase III trials, which if successful will lead to improved treatment for A-ADHD/S-SUD.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Adderall-XR 60 mg | Experimental | Adderall-XR 60 mg |
|
| Adderall-XR 80 mg | Experimental | Adderall-XR 80 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo group |
| |
| Adderall-XR |
| Measure | Description | Time Frame |
|---|---|---|
| Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use | Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE <300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing. | weekly for 14 weeks of trial or for length of participation |
| ADHD Symptoms Based on ADHD Rating Scale | The proportion of subjects exhibiting >30% reduction of AISRS score at last enrollment week compared to week 0 | measured once per week for 14 weeks or length of study participation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frances R Levin, MD | Columbia University | Principal Investigator |
| John Grabowski | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Research Center/Fairview University Psychiatry Dept | Minneapolis | Minnesota | 55454 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25887096 | Derived | Levin FR, Mariani JJ, Specker S, Mooney M, Mahony A, Brooks DJ, Babb D, Bai Y, Eberly LE, Nunes EV, Grabowski J. Extended-Release Mixed Amphetamine Salts vs Placebo for Comorbid Adult Attention-Deficit/Hyperactivity Disorder and Cocaine Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Jun;72(6):593-602. doi: 10.1001/jamapsychiatry.2015.41. |
| Label | URL |
|---|---|
| Substance Treatment and Research Service of Columbia University | View source |
Not provided
Study consisted of a one week single blind placebo run-in prior to group assignment. 139 participants were enrolled and 126 were randomized following the placebo run-up
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo: Placebo group |
| FG001 | Adderall-XR 60 mg | Adderall-XR 60 mg Adderall-XR: Adderall-XR 60mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Adderall-XR 60mg/day |
|
|
| Adderall-XR | Drug | Adderall-XR 80mg/day |
|
|
| STARS |
| New York |
| New York |
| 10032 |
| United States |
| FG002 | Adderall-XR 80 mg | Adderall-XR 80 mg Adderall-XR: Adderall-XR 80mg/day |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Description of 126 participants randomized to study arms.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: Placebo group |
| BG001 | Adderall-XR 60 mg | Adderall-XR 60 mg Adderall-XR: Adderall-XR 60mg/day |
| BG002 | Adderall-XR 80 mg | Adderall-XR 80 mg Adderall-XR: Adderall-XR 80mg/day |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Days of cocaine use (prior 28 days) | Mean | Standard Deviation | DAYS |
|
| 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 | Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use | Each week after randomization was scored dichotomously as cocaine positive or negative. Cocaine use was positive if any urine or self-report was positive. Cocaine use was negative if all urines (BE <300 ng/ml) and all self-report were negative. Weeks with no urine or no self-report were designated missing. | Posted | Number | percentage of participants | weekly for 14 weeks of trial or for length of participation |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | ADHD Symptoms Based on ADHD Rating Scale | The proportion of subjects exhibiting >30% reduction of AISRS score at last enrollment week compared to week 0 | Posted | Number | participants | measured once per week for 14 weeks or length of study participation |
|
|
During 14 weeks of trial or length of study participation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo: Placebo group | 2 | 43 | 8 | 43 | ||
| EG001 | Adderall-XR 60 mg | Adderall-XR 60 mg Adderall-XR: Adderall-XR 60mg/day | 0 | 40 | 19 | 40 | ||
| EG002 | Adderall-XR 80 mg | Adderall-XR 80 mg Adderall-XR: Adderall-XR 80mg/day | 0 | 43 | 19 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| rape | General disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | General disorders | Systematic Assessment |
| ||
| Dry Mouth | General disorders | Systematic Assessment |
| ||
| Decreased Appetite | General disorders | Systematic Assessment |
| ||
| Fidgety/Jittery | General disorders | Systematic Assessment |
| ||
| headache | General disorders | Systematic Assessment |
| ||
| Racing heart | Cardiac disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
|
The dropout rate was relatively low, however, there were dropouts, and this does introduce uncertainly into the outcome assessment. Since all patients received CBT we cannot conclude whether CBT is necessary to derive benefit from the medication.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frances R. Levin, M.D. | Columbia University | 646-774-6137 | frl2@columbia.edu |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C449521 | SLI381 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|