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

April 22, 2019 updated by: Frances R Levin, New York State Psychiatric Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Ambulatory Research Center/Fairview University Psychiatry Dept
    • New York
      • New York, New York, United States, 10032
        • STARS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo group
Experimental: Adderall-XR 60 mg
Drug: Adderall-XR
Adderall-XR 60mg/day
Other Names:
  • Extended-Release Mixed Amphetamine Salts (Adderall-XR)
Drug: Adderall-XR
Adderall-XR 80mg/day
Other Names:
  • Extended-Release Mixed Amphetamine Salts (Adderall-XR)
Experimental: Adderall-XR 80 mg
Drug: Adderall-XR
Adderall-XR 60mg/day
Other Names:
  • Extended-Release Mixed Amphetamine Salts (Adderall-XR)
Drug: Adderall-XR
Adderall-XR 80mg/day
Other Names:
  • Extended-Release Mixed Amphetamine Salts (Adderall-XR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use
Time Frame: weekly for 14 weeks of trial or for length of participation
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
Time Frame: measured once per week for 14 weeks or length of study participation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Frances R Levin, MD, Columbia University
  • Principal Investigator: John Grabowski, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5502/6569R.
  • R01DA023652-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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