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Adult Attention Deficit Hyperactivity DisorderPhase 2/3CAMPNCT00553319

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

A Phase 2/3 study testing Adderall-XR in people with Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence, run by New York State Psychiatric Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Adderall-XR
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
139 participants
Where
2 sitesUnited States
Study dates
Dec 2007to Jul 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Ambulatory Research Center/Fairview University Psychiatry Dept

    Minneapolis, Minnesota, 55454

  • STARS

    New York, New York, 10032

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Placebo, Adderall-XR
Keywords
ADHD, Cocaine, Treatment
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo group

  • Adderall-XRDrug

    Also called Extended-Release Mixed Amphetamine Salts (Adderall-XR)

    Adderall-XR 60mg/day

  • Adderall-XRDrug

    Also called Extended-Release Mixed Amphetamine Salts (Adderall-XR)

    Adderall-XR 80mg/day

Study groups in NCT00553319
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
Adderall-XR 60 mgExperimentalAdderall-XR 60 mg
Receives: Drug: Adderall-XR
Adderall-XR 80 mgExperimentalAdderall-XR 80 mg
Receives: Drug: Adderall-XR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: weekly for 14 weeks of trial or for length of participation

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJul 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00553319
Sponsor's protocol ID
#5502/6569R.
Other IDs
R01DA023652-01
Acronym
CAMP
Status last verified
Apr 2019
First submitted
2 Nov 2007
Last updated
24 Apr 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25887096

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Adderall-XR in people with Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence, run by New York State Psychiatric Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00553319, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.

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