Cocaine Dependence
Conditions
Keywords
cocaine dependence, cocaine abuse, cocaine, crack
Brief summary
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.
Detailed description
We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.
Interventions
DRUGOndansetron
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
DRUGPlacebo
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Sponsors
National Institute on Drug Abuse (NIDA)
University of Virginia
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females who have given written informed consent. * Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg. * Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters. * Current DSM-IV diagnosis of cocaine dependence. * At least one positive urine drug screen for cocaine at screen or baseline prior to randomization. * The pregnancy test for females at intake must be negative. * Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments. * Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine. * Willing to participate in behavioral treatments for cocaine dependence.
Exclusion criteria
Please contact site for additional information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cocaine Use by Self-report | up to 9 weeks | Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report |
| Cocaine Use by Urine Benzoylecgonine | up to 9 weeks | Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ondansetron Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Ondansetron: 4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy | 53 |
| Placebo Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
Placebo: twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy | 55 |
| Total | 108 |
Baseline characteristics
| Characteristic | Total | Placebo | Ondansetron |
|---|---|---|---|
| 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 | 108 Participants | 55 Participants | 53 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian American or Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 85 Participants | 45 Participants | 40 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 21 Participants | 9 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 108 participants | 55 participants | 53 participants |
| Sex: Female, Male Female | 42 Participants | 22 Participants | 20 Participants |
| Sex: Female, Male Male | 66 Participants | 33 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 55 |
| other Total, other adverse events | 44 / 53 | 47 / 55 |
| serious Total, serious adverse events | 1 / 53 | 1 / 55 |
Outcome results
Primary
Cocaine Use by Self-report
Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Time frame: up to 9 weeks
Population: All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ondansetron | Cocaine Use by Self-report | 67 Percent of cocaine-free (abstinent)days | Standard Deviation 0.25 |
| Placebo | Cocaine Use by Self-report | 67 Percent of cocaine-free (abstinent)days | Standard Deviation 0.22 |
Comparison: Difference between ondansetron and placebo groups regarding percentage of cocaine-free days (PCFD)p-value: 0.97295% CI: [-5.43, 5.25]Regression, Linear
Primary
Cocaine Use by Urine Benzoylecgonine
Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine
Time frame: up to 9 weeks
Population: All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ondansetron | Cocaine Use by Urine Benzoylecgonine | 16 Percent of cocaine-free urines | Standard Deviation 0.32 |
| Placebo | Cocaine Use by Urine Benzoylecgonine | 26 Percent of cocaine-free urines | Standard Deviation 0.33 |
Comparison: Difference between ondansetron and placebo groups regarding percentage of cocaine free urines (PCFU)p-value: 0.90995% CI: [-7.08, 7.95]Regression, Linear