Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence

Cocaine Dependence Clinical Trial

— CAMP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553319
• Other study ID #: #5502/6569R.
• Secondary ID: R01DA023652-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 2007
• Est. completion date: July 2013

Study information

• Verified date: April 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence and adult ADHD (DSM-IV-TR).

2. Used cocaine at least four days in the past month

3. Must have a Body Mass Index (BMI) > 18 kg/m2

4. Alcohol Breathalyzer (BraC) at consent of < 0.04%

5. Individuals must be capable of giving informed consent and capable of complying with study procedures.

6. 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:

1. Meets DSM-IV-TR criteria for bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.

2. 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.

3. 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.

4. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention.

5. Individuals with current suicidal risk.

6. 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.

7. 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.

8. Individuals with a history of seizures

9. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS).

10. Women who are pregnant or nursing.

11. History of failure to respond to a previous adequate trial of the candidate medication for cocaine dependence

12. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program

13. History of glaucoma

14. Individuals who report use of MAOI within 14 days of study start

Related Conditions & MeSH terms

• Adult Attention Deficit Hyperactivity Disorder
• Attention Deficit Disorder with Hyperactivity
• Cocaine Dependence
• Cocaine-Related Disorders
• Disease
• Hyperkinesis

Intervention

Drug:
• Placebo
Placebo group
• Adderall-XR
Adderall-XR 60mg/day
• Adderall-XR
Adderall-XR 80mg/day

Locations

Country	Name	City	State
United States	Ambulatory Research Center/Fairview University Psychiatry Dept	Minneapolis	Minnesota
United States	STARS	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	measured once per week for 14 weeks or length of study participation

External Links

•   Substance Treatment and Research Service of Columbia University