Substance Abuse
Conditions
Keywords
cocaine, dependence, stimulants
Brief summary
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.
Interventions
DRUGatomoxetine
Once daily oral dosing
DRUGplacebo
Once daily oral dosing - matched placebo
Sponsors
Eli Lilly and Company
National Institute on Drug Abuse (NIDA)
Sharon Walsh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Seeking treatment for cocaine dependence * Must have used cocaine in the past 30 days
Exclusion criteria
* Physical dependence on any drug requiring medical management * Any major medical or psychiatric disorder that would be contraindicated for participation * Cardiovascular disease * Seizures or significant head injuries * Currently taking atomoxetine * Pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Urine Samples Negative for Cocaine | Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks | Total % urine samples negative for benzoylecgonine over the 12-week trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention | 12-weeks | Trial retention- those who complete the 12 week dosing period |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matched placebo | 25 |
| Atomoxetine Atomoxetine (80 mg/day) | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 13 |
Baseline characteristics
| Characteristic | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 44.5 years STANDARD_DEVIATION 1.6 | 41.6 years STANDARD_DEVIATION 1.6 | 42 years STANDARD_DEVIATION 1.7 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex/Gender, Customized Female | 19 participants | 8 participants | 27 participants |
| Sex/Gender, Customized Male | 6 participants | 17 participants | 23 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
% Urine Samples Negative for Cocaine
Total % urine samples negative for benzoylecgonine over the 12-week trial
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | % Urine Samples Negative for Cocaine | .67 percentage of positive urine samples |
| Atomoxetine | % Urine Samples Negative for Cocaine | .74 percentage of positive urine samples |
Secondary
Retention
Trial retention- those who complete the 12 week dosing period
Time frame: 12-weeks
Population: those completing the 12-week study after randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Retention | 57.4 days | Standard Error 7 |
| Atomoxetine | Retention | 51.6 days | Standard Error 6.7 |