Cocaine Addiction, Cocaine Dependence
Conditions
Keywords
Cocaine, Cocaine Addiction Treatment, Cocaine Treatment, Vigabatrin, CPP-109, Catalyst, National Institute on Drug Abuse
Brief summary
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.
Detailed description
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling. There are 3 Phases to this study: * a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested; * a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and * a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling.
Interventions
DRUGVigabatrin
Tablets
DRUGMatching Placebo
Tablets
Sponsors
National Institute on Drug Abuse (NIDA)
VA Office of Research and Development
Catalyst Pharmaceuticals, Inc.
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
* Able to understand the study and provide written informed consent. * Male or female at least 18 years of age. * Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual-IV (DSM-IV) module. * Have a verifiable place of primary residence. * Seeking treatment for cocaine dependence. * Be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings. * If female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (IUD), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable.
Exclusion criteria
* Please contact site for more information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence | Weeks 8-9 | The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9). |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Cocaine Use | Week 3 - 9 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CPP-109 Vigabatrin Tablets Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks. | 103 |
| Placebo Participants received Vigabatrin placebo table orally once daily for 7 weeks. | 104 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 2 | 8 |
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Incarceration | 0 | 3 |
| Overall Study | Lost to Follow-up | 11 | 13 |
| Overall Study | Protocol Violation | 11 | 10 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | CPP-109 Vigabatrin Tablets | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 7.5 | 46.6 years STANDARD_DEVIATION 7.5 | 47.2 years STANDARD_DEVIATION 7.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 35 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 169 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 55 Participants | 107 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) White | 39 Participants | 78 Participants | 39 Participants |
| Region of Enrollment United States | 103 participants | 207 participants | 104 participants |
| Sex: Female, Male Female | 29 Participants | 62 Participants | 33 Participants |
| Sex: Female, Male Male | 74 Participants | 145 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 84 / 103 | 89 / 104 |
| serious Total, serious adverse events | 6 / 103 | 3 / 104 |
Outcome results
Primary
Abstinence
The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).
Time frame: Weeks 8-9
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPP-109 Vigabatrin Tablets | Abstinence | 5 participants |
| Matching Placebo | Abstinence | 9 participants |
Secondary
Number of Participants With Cocaine Use
Time frame: Week 3 - 9
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CPP-109 Vigabatrin Tablets | Number of Participants With Cocaine Use | Week 5 | 88 participants |
| CPP-109 Vigabatrin Tablets | Number of Participants With Cocaine Use | Week 7 | 84 participants |
| CPP-109 Vigabatrin Tablets | Number of Participants With Cocaine Use | Week 4 | 91 participants |
| CPP-109 Vigabatrin Tablets | Number of Participants With Cocaine Use | Week 8 | 83 participants |
| CPP-109 Vigabatrin Tablets | Number of Participants With Cocaine Use | Week 6 | 86 participants |
| CPP-109 Vigabatrin Tablets | Number of Participants With Cocaine Use | Week 9 | 81 participants |
| CPP-109 Vigabatrin Tablets | Number of Participants With Cocaine Use | Week 3 | 95 participants |
| Matching Placebo | Number of Participants With Cocaine Use | Week 9 | 81 participants |
| Matching Placebo | Number of Participants With Cocaine Use | Week 3 | 96 participants |
| Matching Placebo | Number of Participants With Cocaine Use | Week 4 | 95 participants |
| Matching Placebo | Number of Participants With Cocaine Use | Week 5 | 93 participants |
| Matching Placebo | Number of Participants With Cocaine Use | Week 6 | 90 participants |
| Matching Placebo | Number of Participants With Cocaine Use | Week 7 | 85 participants |
| Matching Placebo | Number of Participants With Cocaine Use | Week 8 | 82 participants |