Trial Outcomes & Findings for Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial (NCT NCT00617201)

Results Overview

Total % urine samples negative for benzoylecgonine over the 12-week trial

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks

Results posted on

2017-08-31

Participant Flow

Adult volunteers ages 18-60 reporting cocaine use in the preceding 30 days who met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for and were seeking treatment for cocaine dependence were recruited through advertisements and word-of-mouth to a research clinic.

Exclusions included dependence on any drug requiring detoxification, other Axis I disorders, medical problems, pregnant or lactating females, Cytochrome P450 2D6 inhibitors/inducers, monoamine oxidase inhibitors or selective serotonin reuptake inhibitors. Enrollment in other drug treatment programs urine samples required for parole/probation.

Participant milestones

Participant milestones
Measure	Atomoxetine (80 mg/Day) Active drug atomoxetine : Once daily oral dosing	Matched Placebo Matched Placebo placebo : Once daily oral dosing - matched placebo
Overall Study STARTED	25	25
Overall Study COMPLETED	16	12
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Atomoxetine (80 mg/Day) Active drug atomoxetine : Once daily oral dosing	Matched Placebo Matched Placebo placebo : Once daily oral dosing - matched placebo
Overall Study Lost to Follow-up	9	13

Baseline Characteristics

Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=25 Participants Matched placebo	Atomoxetine n=25 Participants Atomoxetine (80 mg/day)	Total n=50 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	25 Participants n=5 Participants	25 Participants n=7 Participants	50 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	41.6 years STANDARD_DEVIATION 1.6 • n=5 Participants	44.5 years STANDARD_DEVIATION 1.6 • n=7 Participants	42 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex/Gender, Customized Female	8 participants n=5 Participants	19 participants n=7 Participants	27 participants n=5 Participants
Sex/Gender, Customized Male	17 participants n=5 Participants	6 participants n=7 Participants	23 participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks

Population: Intent-to-treat analysis included all subjects with missing urine sample counted as positive.

Total % urine samples negative for benzoylecgonine over the 12-week trial

Outcome measures

Outcome measures
Measure	Placebo n=598 Urine samples Matched Placebo	Atomoxetine n=537 Urine samples 80 mg/day (after intial 4-day run up)
% Urine Samples Negative for Cocaine	.67 percentage of positive urine samples	.74 percentage of positive urine samples

SECONDARY outcome

Timeframe: 12-weeks

Population: those completing the 12-week study after randomization

Trial retention- those who complete the 12 week dosing period

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Matched Placebo	Atomoxetine n=25 Participants 80 mg/day (after intial 4-day run up)
Retention	57.4 days Standard Error 7	51.6 days Standard Error 6.7

Adverse Events

Atomoxetine (80 mg/Day)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Matched Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sharon Walsh

University of Kentucky

Phone: 859-257-2684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place