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

Primary Purpose

Adult Attention Deficit Hyperactivity Disorder, Cocaine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

Adderall-XR

About this trial

This is an interventional treatment trial for Adult Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Cocaine, Treatment

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 < 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.

Exclusion Criteria:

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

Sites / Locations

Ambulatory Research Center/Fairview University Psychiatry Dept
STARS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Adderall-XR 60 mg

Adderall-XR 80 mg

Arm Description

Placebo

Adderall-XR 60 mg

Adderall-XR 80 mg

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00553319

First Posted

November 2, 2007

Last Updated

April 22, 2019

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00553319

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

December 2007 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Attention Deficit Hyperactivity Disorder, Cocaine Dependence

Keywords

ADHD, Cocaine, Treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Adderall-XR 60 mg

Arm Type

Experimental

Arm Description

Adderall-XR 60 mg

Arm Title

Adderall-XR 80 mg

Arm Type

Experimental

Arm Description

Adderall-XR 80 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo group

Intervention Type

Drug

Intervention Name(s)

Adderall-XR

Other Intervention Name(s)

Extended-Release Mixed Amphetamine Salts (Adderall-XR)

Intervention Description

Adderall-XR 60mg/day

Intervention Type

Drug

Intervention Name(s)

Adderall-XR

Other Intervention Name(s)

Extended-Release Mixed Amphetamine Salts (Adderall-XR)

Intervention Description

Adderall-XR 80mg/day

Primary Outcome Measure Information:

Title

Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use

Description

Time Frame

weekly for 14 weeks of trial or for length of participation

Title

ADHD Symptoms Based on ADHD Rating Scale

Description

The proportion of subjects exhibiting >30% reduction of AISRS score at last enrollment week compared to week 0

Time Frame

measured once per week for 14 weeks or length of study participation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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 < 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frances R Levin, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

John Grabowski

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ambulatory Research Center/Fairview University Psychiatry Dept

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Facility Name

STARS

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25887096

Citation

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.

Results Reference

derived

Links:

URL

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

Description

Substance Treatment and Research Service of Columbia University

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

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