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

NCT ID: NCT00553319

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2013-07-31

Brief 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.

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.

Conditions

Adult Attention Deficit Hyperactivity Disorder; Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo group

Adderall-XR 60 mg

Adderall-XR 60 mg

Group Type: EXPERIMENTAL

Adderall-XR

Intervention Type: DRUG

Adderall-XR 60mg/day

Adderall-XR 80 mg

Adderall-XR 80 mg

Group Type: EXPERIMENTAL

Adderall-XR

Intervention Type: DRUG

Adderall-XR 80mg/day

Interventions

Placebo

Placebo group

Intervention Type: DRUG

Adderall-XR

Adderall-XR 60mg/day

Intervention Type: DRUG

Adderall-XR

Adderall-XR 80mg/day

Intervention Type: DRUG

Other Intervention Names

Extended-Release Mixed Amphetamine Salts (Adderall-XR); Extended-Release Mixed Amphetamine Salts (Adderall-XR)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Frances R Levin

Director of Substance Use Disorder

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frances R Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

John Grabowski

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Ambulatory Research Center/Fairview University Psychiatry Dept

Minneapolis, Minnesota, United States

STARS

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25887096 (View on PubMed)

Related Links

http://www.stars.columbia.edu/

Substance Treatment and Research Service of Columbia University

Other Identifiers

R01DA023652-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#5502/6569R.

Identifier Type: -

Identifier Source: org_study_id