Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence (CAMP)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adult Attention Deficit Hyperactivity Disorder Cocaine Dependence |
Drug: Placebo Drug: Adderall-XR |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence |
- cocaine urine toxicology results [ Time Frame: 3x/week for 14 weeks of trial or for length of participation ] [ Designated as safety issue: No ]
- ADHD symptoms based on ADHD Rating Scale [ Time Frame: measured once per week for 14 weeks or length of study participation ] [ Designated as safety issue: No ]
- ADHD symptoms based on CGI [ Time Frame: measured weekly during 14 weeks or length of study participation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo group
|
|
Experimental: Adderall-XR 60 mg
Adderall-XR 60 mg
|
Drug: Adderall-XR
Adderall-XR 60mg/day
Other Name: Extended-Release Mixed Amphetamine Salts (Adderall-XR)
|
|
Experimental: Adderall-XR 80 mg
Adderall-XR 80 mg
|
Drug: Adderall-XR
Adderall-XR 80mg/day
Other Name: Extended-Release Mixed Amphetamine Salts (Adderall-XR)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence and adult ADHD (DSM-IV-TR).
- Used cocaine at least four days in the past month
- Must have a Body Mass Index (BMI) > 18 kg/m2
- Alcohol Breathalyzer (BraC) at consent of < 0.04%
- Individuals must be capable of giving informed consent and capable of complying with study procedures.
- Women of child bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
Exclusion Criteria:
- Meets DSM-IV-TR criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
- Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR supported by the SCID-I/P that in the investigator's judgment are unstable or would be disrupted by study medication or are likely to require pharmacotherapy during the study period.
- Individuals with current major depressive disorder.However,individuals who are currently stable on a psychotropic medication for three months with a HAM-D <14 may be included.
- Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention.
- Individuals with current suicidal risk.
- Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG, cardiac symptoms, fainting, open-heart surgery and/or arrhythmia, and family history of ventricular tachycardia/sudden death.
- Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 3x upper limit of normal are acceptable), or uncontrolled diabetes.
- Individuals with a history of seizures
- History of allergic reaction to candidate medication (amphetamine and/or ER-MAS).
- Women who are pregnant or nursing.
- History of failure to respond to a previous adequate trial of the candidate medication for cocaine dependence
- Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program
- History of glaucoma
- Individuals who report use of MAOI within 14 days of study start
Contacts and Locations| Contact: Amy Mahony, MA | 212-740-7351 | mahonya@nyspi.columbia.edu |
| Contact: Daniel Brooks, MA | 212-740-3205 | brooksd@nyspi.columbia.edu |
| United States, Minnesota | |
| Ambulatory Research Center/Fairview University Psychiatry Dept | Recruiting |
| Minneapolis, Minnesota, United States, 55454 | |
| Contact: David Babb 612-627-4824 babbx001@umn.edu | |
| Contact: Carla Amundson, M.A. CMAMUN01@smumn.edu | |
| Principal Investigator: John Grabowski, PhD | |
| United States, New York | |
| STARS | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Amy Mahony, MA 212-740-7351 mahonya@pi.cpmc.columbia.edu | |
| Contact: Daniel Brooks, MA 212-740-3205 brooksd@pi.cpmc.columbia.edu | |
| Principal Investigator: Frances R Levin, MD | |
| Principal Investigator: | Frances R Levin, MD | Columbia University |
| Principal Investigator: | John Grabowski | University of Minnesota - Clinical and Translational Science Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00553319 History of Changes |
| Other Study ID Numbers: | #5502/6569R., R01DA023652-01 |
| Study First Received: | November 2, 2007 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New York State Psychiatric Institute:
|
ADHD Cocaine Treatment |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Cocaine-Related Disorders Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Substance-Related Disorders Amphetamine Methamphetamine Adderall Cocaine |
Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013