Phase 3
N=126
Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence
Adult Attention Deficit Hyperactivity Disorder · Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00553319 ↗Enrolled (actual)
126
Serious AEs
1.6%
Results posted
Sep 2014
Primary outcome: Primary: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use — 7; 18; 30 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Adderall-XR (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use |
7; 18; 30 | — |
| PRIMARY ADHD Symptoms Based on ADHD Rating Scale |
17; 30; 25 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00553319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.