Trial Outcomes & Findings for Atomoxetine Treatment for ADHD and Marijuana Dependence (NCT NCT00360269)

NCT ID: NCT00360269

Last Updated: 2014-12-30

Results Overview

Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 38 participants
• Primary outcome timeframe: One week (study week 12)
• Results posted on: 2014-12-30

Participant Flow

Participants recruited between November 2005 and June 2008 primarily through media advertisements and fliers

Participant milestones

Measure	Atomoxetine Flexible dose up to 100mg/day	Placebo Flexible dose up to 100mg/day
Overall Study STARTED	19	19
Overall Study COMPLETED	9	7
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Measure	Atomoxetine Flexible dose up to 100mg/day	Placebo Flexible dose up to 100mg/day
Overall Study Lost to Follow-up	7	9
Overall Study Physician Decision	1	2
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Atomoxetine Treatment for ADHD and Marijuana Dependence

Baseline characteristics by cohort

Measure	Atomoxetine n=19 Participants Flexible dose up to 100mg/day	Placebo n=19 Participants Flexible dose up to 100mg/day	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.4 years STANDARD_DEVIATION 10.0 • n=5 Participants	30.4 years STANDARD_DEVIATION 13.0 • n=7 Participants	29.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	19 participants n=7 Participants	38 participants n=5 Participants

PRIMARY outcome

Timeframe: One week (study week 12)

Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back.

Outcome measures

Measure	Atomoxetine n=19 Participants Flexible dose up to 100mg/day	Placebo n=19 Participants Flexible dose up to 100mg/day
Estimated Week 12 Self-reported Use	2.17 Times per day Standard Error .34	1.84 Times per day Standard Error .34

SECONDARY outcome

Timeframe: 12 weeks

Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back.

Outcome measures

Measure	Atomoxetine n=19 Participants Flexible dose up to 100mg/day	Placebo n=19 Participants Flexible dose up to 100mg/day
Self-reported Longitudinal Use	60.1 Percentage of days used Standard Deviation 31.5	68.1 Percentage of days used Standard Deviation 31.3

SECONDARY outcome

Timeframe: 12 weeks

Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.

Outcome measures

Measure	Atomoxetine n=19 Participants Flexible dose up to 100mg/day	Placebo n=19 Participants Flexible dose up to 100mg/day
Urine Drug Screens	87.3 Percentage of positive UDS	85.3 Percentage of positive UDS

SECONDARY outcome

Timeframe: Baseline and Week 12

The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0-2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF).

Outcome measures

Measure	Atomoxetine n=19 Participants Flexible dose up to 100mg/day	Placebo n=19 Participants Flexible dose up to 100mg/day
Wender-Reimherr Adult Attention Deficit Disorder Scale	-15.05 Units on a scale Standard Deviation 10.96	-11.05 Units on a scale Standard Deviation 7.59

SECONDARY outcome

Timeframe: 12 weeks

The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

Outcome measures

Measure	Atomoxetine n=19 Participants Flexible dose up to 100mg/day	Placebo n=19 Participants Flexible dose up to 100mg/day
Clinical Global Impression, Improvement Scale	2.63 Units on a scale Standard Deviation 0.68	3.26 Units on a scale Standard Deviation 0.93

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Atomoxetine n=19 participants at risk Flexible dose up to 100mg/day	Placebo n=19 participants at risk Flexible dose up to 100mg/day
Psychiatric disorders Anxiety/depression	15.8% 3/19	10.5% 2/19
Nervous system disorders Dizziness/lightheaded	31.6% 6/19	15.8% 3/19
Nervous system disorders Drowsiness	15.8% 3/19	15.8% 3/19
General disorders Dry mouth	15.8% 3/19	15.8% 3/19
Gastrointestinal disorders Gastrointestinal	47.4% 9/19	21.1% 4/19
Nervous system disorders Headache	36.8% 7/19	26.3% 5/19
General disorders Hot/cold flashes	15.8% 3/19	0.00% 0/19
Renal and urinary disorders Increased urination	0.00% 0/19	10.5% 2/19
General disorders Insomnia	0.00% 0/19	21.1% 4/19
Psychiatric disorders Irritability	10.5% 2/19	5.3% 1/19
Musculoskeletal and connective tissue disorders Musculoskeletal	31.6% 6/19	26.3% 5/19
Respiratory, thoracic and mediastinal disorders Respiratory	0.00% 0/19	5.3% 1/19
Reproductive system and breast disorders Sexual dysfunction	26.3% 5/19	0.00% 0/19
General disorders Sinus/allergies/flu-like symptoms	36.8% 7/19	47.4% 9/19
General disorders Other	26.3% 5/19	15.8% 3/19

Additional Information

Aimee McRae-Clark, Pharm.D., BCPP

Medical University of South Carolina

Phone: 843-792-5215

Email: mcraeal@musc.edu

Results disclosure agreements

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