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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 : November 28, 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
Enrollment 20
Recruitment Details 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  
Arm/Group Title Atomoxetine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 20
Completed 5 [1]
Not Completed 15
Reason Not Completed
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.
Arm/Group Title Atomoxetine
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
39.3  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
1
   5.0%
Male
19
  95.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title the Adult ADHD Rating Scale (AARS) (30% Reduction)
Hide Description AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.
Time Frame baseline compared to rating at week 12 or last rating during study participation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percent of participants
50
2.Primary Outcome
Title ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)
Hide Description Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.
Time Frame measured during 12 weeks or length of study participation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed
Arm/Group Title Atomoxetine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: scores on a scale
baseline 31.4  (9.8)
end of study 21.2  (12.4)
Time Frame 12 weeks or length of study participation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atomoxetine
Hide Arm/Group Description 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.
All-Cause Mortality
Atomoxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atomoxetine
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atomoxetine
Affected / at Risk (%) # Events
Total   5/20 (25.00%)    
Cardiac disorders   
chest pain   1/20 (5.00%)  1
Gastrointestinal disorders   
nausea   2/20 (10.00%)  2
General disorders   
headache   1/20 (5.00%)  1
dizziness   1/20 (5.00%)  1
Psychiatric disorders   
anxiety   2/20 (10.00%)  2
Indicates events were collected by systematic assessment
Clearly, there are limitations of this study including the high drop-out rate, small sample size, and lack of a control group.
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
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: November 28, 2018