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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01281202
Other study ID # CPP-01005/CS# 1030 TRANSFERRED
Secondary ID Y1-DA4006
Status Completed
Phase Phase 2/Phase 3
First received January 20, 2011
Last updated May 16, 2016
Start date January 2011
Est. completion date December 2012

Study information

Verified date May 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date December 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Vigabatrin
Tablets
Matching Placebo
Tablets

Locations

Country Name City State
United States Pacific Institute for Research and Evaluation Albuquerque New Mexico
United States Mountain Manor Treatment Center @ Baltimore Baltimore Maryland
United States Boston University School of Medicine Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Pillar Clinical Research, LLC Dallas Texas
United States VA Medical Center Denver Colorado
United States University of Texas Health Science Center at Houston Houston Texas
United States Matrix Institute on Addictions Los Angeles California
United States University of Miami School of Medicine Miami Florida
United States NeuroPsychiatric Research & Practice Assoc., Ltd. Oak Brook Illinois
United States Western Psychiatric Inst. and Clinic Pittsburgh Pennsylvania
United States George E Wahlen VA Medical Center Salt Lake City Utah
United States Friends Research Institute Torrance California

Sponsors (3)

Lead Sponsor Collaborator
Catalyst Pharmaceuticals, Inc. National Institute on Drug Abuse (NIDA), VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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). Weeks 8-9 Yes
Secondary Number of Participants With Cocaine Use Week 3 - 9 No
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