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

NCT00553319 | Completed Phase 2 Results DMC

• 2 other identifiers: #5502/6569R.R01DA023652-01
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 2

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.

Conditions

Adult Attention Deficit Hyperactivity Disorder; Cocaine Dependence

Keywords

ADHD; Cocaine; Treatment

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Adderall-XR 60 mg

EXPERIMENTAL

Adderall-XR 60 mg

Drug: Adderall-XR

Adderall-XR 80 mg

EXPERIMENTAL

Adderall-XR 80 mg

Drug: Adderall-XR

Interventions

Placebo DRUG

Placebo group

Placebo

Adderall-XR DRUG

Adderall-XR 60mg/day

Also known as: Extended-Release Mixed Amphetamine Salts (Adderall-XR)

Adderall-XR 60 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Ambulatory Research Center/Fairview University Psychiatry Dept

Minneapolis, Minnesota, 55454, United States

Location

STARS

New York, New York, 10032, United States

Location

Related Publications (1)

• 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.

  PMID: 25887096 DERIVED

Related Links

• Substance Treatment and Research Service of Columbia University

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Cocaine-Related Disorders

Interventions

SLI381

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Frances R. Levin, M.D.
• Organization: Columbia University

frl2@columbia.edu

646-774-6137

Study Officials

• Frances R Levin, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• John Grabowski

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 24, 2019
• Results First Posted: September 1, 2014

Record last verified: 2019-04

Locations

US (2)