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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00553319
First received: November 2, 2007
Last updated: August 20, 2014
Last verified: August 2014
Results First Received: August 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Adult Attention Deficit Hyperactivity Disorder
Cocaine Dependence
Interventions: Drug: Placebo
Drug: Adderall-XR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Study consisted of a one week single blind placebo run-in prior to group assignment. 139 participants were enrolled and 126 were randomized following the placebo run-in.

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Reporting Groups
  Description
Placebo

Placebo

Placebo: Placebo group

Adderall-XR 60 mg

Adderall-XR 60 mg

Adderall-XR: Adderall-XR 60mg/day

Adderall-XR 80 mg

Adderall-XR 80 mg

Adderall-XR: Adderall-XR 80mg/day


Participant Flow:   Overall Study
    Placebo     Adderall-XR 60 mg     Adderall-XR 80 mg  
STARTED     43     40     43  
COMPLETED     29     30     34  
NOT COMPLETED     14     10     9  
Lost to Follow-up                 10                 9                 5  
wanted treatment elsewhere                 2                 1                 1  
non-compliance                 0                 0                 2  
incarceration                 1                 0                 0  
moved                 1                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Description of 126 participants randomized to study arms.

Reporting Groups
  Description
Placebo

Placebo

Placebo: Placebo group

Adderall-XR 60 mg

Adderall-XR 60 mg

Adderall-XR: Adderall-XR 60mg/day

Adderall-XR 80 mg

Adderall-XR 80 mg

Adderall-XR: Adderall-XR 80mg/day

Total Total of all reporting groups

Baseline Measures
    Placebo     Adderall-XR 60 mg     Adderall-XR 80 mg     Total  
Number of Participants  
[units: participants]
  43     40     43     126  
Age  
[units: YEARS]
Mean ± Standard Deviation
  39.3  ± 7.4     43.9  ± 7.5     38.4  ± 8.6     40.4  ± 8.1  
Gender  
[units: participants]
       
Female     5     7     8     20  
Male     38     33     35     106  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     2     2     1     5  
Asian     0     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     7     9     6     22  
White     24     21     27     72  
More than one race     10     8     8     26  
Unknown or Not Reported     0     0     0     0  
Days of cocaine use (prior 28 days)  
[units: DAYS]
Mean ± Standard Deviation
  11.3  ± 7.5     12.4  ± 7.8     11.3  ± 7.0     11.7  ± 7.4  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   ADHD Symptoms Based on ADHD Rating Scale   [ Time Frame: measured once per week for 14 weeks or length of study participation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Frances R. Levin, M.D.
Organization: Columbia University
phone: 646-774-6137
e-mail: frl2@columbia.edu


No publications provided


Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00553319     History of Changes
Other Study ID Numbers: #5502/6569R., R01DA023652-01
Study First Received: November 2, 2007
Results First Received: August 20, 2014
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration