Cocaine Dependence
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.
Interventions
DRUGNepicastat
120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
DRUGPlacebo
Sponsors
National Institute on Drug Abuse (NIDA)
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 99 Years
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age * Is seeking treatment for cocaine dependence * Is able to understand and provide written informed consent * Has completed all psychological assessments and procedures required during the 7 - 14 day screening period * If female, agrees to use an acceptable method of birth control * Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study
Exclusion criteria
* Please contact the study site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence (Weeks 10 - 11) | Weeks 10 - 11 | Number of subjects that abstained from cocaine from weeks 10 through 11 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Use (Weeks 1 - 11) | Baseline through week 11 | Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nepicastat Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks. | 90 |
| Placebo Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Placebo | 89 |
| Total | 179 |
Baseline characteristics
| Characteristic | Nepicastat | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 8.2 | 49.0 years STANDARD_DEVIATION 8.2 | 49.9 years STANDARD_DEVIATION 8.2 |
| Region of Enrollment United States | 90 participants | 89 participants | 179 participants |
| Sex: Female, Male Female | 15 Participants | 12 Participants | 27 Participants |
| Sex: Female, Male Male | 75 Participants | 77 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 80 / 90 | 67 / 89 |
| serious Total, serious adverse events | 8 / 90 | 2 / 89 |
Outcome results
Primary
Abstinence (Weeks 10 - 11)
Number of subjects that abstained from cocaine from weeks 10 through 11
Time frame: Weeks 10 - 11
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nepicastat | Abstinence (Weeks 10 - 11) | 4 Participants |
| Placebo | Abstinence (Weeks 10 - 11) | 7 Participants |
Secondary
Reduction in Use (Weeks 1 - 11)
Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11
Time frame: Baseline through week 11
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nepicastat | Reduction in Use (Weeks 1 - 11) | 13 participants |
| Placebo | Reduction in Use (Weeks 1 - 11) | 20 participants |