Trial Outcomes & Findings for Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00218543)

NCT ID: NCT00218543

Last Updated: 2019-04-24

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: baseline compared to rating at week 12 or last rating during study participation
• Results posted on: 2019-04-24

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	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.
Overall Study Lost to Follow-up	8
Overall Study relocated	1
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	3
Overall Study Adverse Event	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Atomoxetine n=20 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline compared to rating at week 12 or last rating during study participation

Population: All participants

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.

Outcome measures

Measure

Atomoxetine n=20 Participants 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.

the Adult ADHD Rating Scale (AARS) (30% Reduction)

50 percent of participants

PRIMARY outcome

Timeframe: measured during 12 weeks or length of study participation

Population: Comparing overall baseline scores to end of study scores for patients who had at least two AARS weekly measures completed

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.

Outcome measures

Measure	Atomoxetine n=18 Participants 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.
ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS) baseline	31.4 scores on a scale Standard Deviation 9.8
ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS) end of study	21.2 scores on a scale Standard Deviation 12.4

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Atomoxetine n=20 participants at risk 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.
Gastrointestinal disorders nausea	10.0% 2/20 • Number of events 2 • 12 weeks or length of study participation
General disorders headache	5.0% 1/20 • Number of events 1 • 12 weeks or length of study participation
Cardiac disorders chest pain	5.0% 1/20 • Number of events 1 • 12 weeks or length of study participation
Psychiatric disorders anxiety	10.0% 2/20 • Number of events 2 • 12 weeks or length of study participation
General disorders dizziness	5.0% 1/20 • Number of events 1 • 12 weeks or length of study participation

Additional Information

Frances R Levin, MD

COLUMBIA UNIVERSITY

Phone: 212-543-5896

Email: FRL2@COLUMBIA.EDU

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place