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Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD) (Atom)

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ClinicalTrials.gov Identifier: NCT00218543
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : July 4, 2012
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders
Intervention: Drug: Atomoxetine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were seeking treatment for problems related to cocaine use and were recruited by local advertising/referrals in the New York City area. Two types of adS were placed: (1) ads for treatment of cocaine dependence, and (2) ads for treatment for cocaine dependence and possible problems with inattention and/or hyperactivity.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atomoxetine Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.

Participant Flow:   Overall Study
    Atomoxetine
STARTED   20 
COMPLETED   5 [1] 
NOT COMPLETED   15 
Lost to Follow-up                8 
relocated                1 
Withdrawal by Subject                1 
Physician Decision                3 
Adverse Event                2 
[1] 13 reached the maintenance dose phase of treatment; 9 completed at least six weeks of treatment.



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Atomoxetine Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.

Baseline Measures
   Atomoxetine 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.3  (6.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1   5.0% 
Male      19  95.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures

1.  Primary:   the Adult ADHD Rating Scale (AARS) (30% Reduction)   [ Time Frame: baseline compared to rating at week 12 or last rating during study participation ]

2.  Primary:   ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)   [ Time Frame: measured during 12 weeks or length of study participation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
Clearly, there are limitations of this study including the high drop-out rate, small sample size, and lack of a control group.


  More Information

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


Results Point of Contact:  
Name/Title: Frances R Levin, MD
Organization: COLUMBIA UNIVERSITY
phone: 212-543-5896
e-mail: FRL2@COLUMBIA.EDU



Responsible Party: Frances R Levin, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00218543     History of Changes
Other Study ID Numbers: #4611
P50DA009236 ( U.S. NIH Grant/Contract )
P50-09236-12
DPMC
First Submitted: September 20, 2005
First Posted: September 22, 2005
Results First Submitted: January 12, 2012
Results First Posted: July 4, 2012
Last Update Posted: May 15, 2018