Vigabatrin for the Treatment of Cocaine Dependency

• Sponsor: Catalyst Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01281202
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), VA Office of Research and Development (U.S. Fed)
• Enrollment: 207
• Locations: 13
• Arms: 2
• Duration (Months): 23
• Patients Per Site: 15.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Addiction; Cocaine Dependence	Drug: Vigabatrin; Drug: Matching Placebo	Phase 2/Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 207 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CPP-109 Vigabatrin Tablets Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)	Drug: Vigabatrin; Tablets; Other Names: CPP-109 GVG VGB
Placebo Comparator: Placebo Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Indivdiual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)	Drug: Matching Placebo; Tablets

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Number of Participants With Cocaine Use [Week 3 - 9]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Matrix Institute on Addictions	Los Angeles	California	United States	90016
2	Friends Research Institute	Torrance	California	United States	90502
3	VA Medical Center	Denver	Colorado	United States	80220
4	University of Miami School of Medicine	Miami	Florida	United States	33136
5	NeuroPsychiatric Research & Practice Assoc., Ltd.	Oak Brook	Illinois	United States	60523
6	Mountain Manor Treatment Center @ Baltimore	Baltimore	Maryland	United States	21229
7	Boston University School of Medicine	Boston	Massachusetts	United States	02118
8	Pacific Institute for Research and Evaluation	Albuquerque	New Mexico	United States	87102
9	Western Psychiatric Inst. and Clinic	Pittsburgh	Pennsylvania	United States	15213
10	Medical University of South Carolina	Charleston	South Carolina	United States	29403
11	Pillar Clinical Research, LLC	Dallas	Texas	United States	75243
12	University of Texas Health Science Center at Houston	Houston	Texas	United States	77054
13	George E Wahlen VA Medical Center	Salt Lake City	Utah	United States	84148

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Kathleen Brady, MD, PhD, Medical University of South Carolina
• Study Chair: Christopher J Stock, PharmD, George E. Wahlen VA Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catalyst Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01281202
• Other Study ID Numbers: CPP-01005/CS# 1030 TRANSFERRED; Y1-DA4006
• First Posted: Jan 21, 2011
• Last Update Posted: May 18, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Catalyst Pharmaceuticals, Inc.: Cocaine; Cocaine Addiction Treatment; Cocaine Treatment; Vigabatrin; CPP-109; Catalyst; National Institute on Drug Abuse
• Additional relevant MeSH terms: Cocaine-Related Disorders; Behavior, Addictive; Vigabatrin

Study Results

Participant Flow

Arm/Group Title	CPP-109 Vigabatrin Tablets	Placebo
Arm/Group Description	Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.	Participants received Vigabatrin placebo table orally once daily for 7 weeks.
Period Title: Overall Study
STARTED	103	104
COMPLETED	75	68
NOT COMPLETED	28	36

Baseline Characteristics

Arm/Group Title	CPP-109 Vigabatrin Tablets	Placebo	Total
Arm/Group Description	Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.	Participants received Vigabatrin placebo table orally once daily for 7 weeks.	Total of all reporting groups
Overall Participants	103	104	207
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.1 (7.5)	47.2 (7.4)	46.6 (7.5)
Sex: Female, Male (Count of Participants)
Female	29 28.2%	33 31.7%	62 30%
Male	74 71.8%	71 68.3%	145 70%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	17 16.5%	18 17.3%	35 16.9%
Not Hispanic or Latino	84 81.6%	85 81.7%	169 81.6%
Unknown or Not Reported	2 1.9%	1 1%	3 1.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 1.9%	2 1%
Asian	1 1%	0 0%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	55 53.4%	52 50%	107 51.7%
White	39 37.9%	39 37.5%	78 37.7%
More than one race	3 2.9%	3 2.9%	6 2.9%
Unknown or Not Reported	5 4.9%	8 7.7%	13 6.3%
Region of Enrollment (participants) [Number]
United States	103 100%	104 100%	207 100%

Outcome Measures

1. Primary Outcome

Title	Abstinence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CPP-109 Vigabatrin Tablets	Matching Placebo
Arm/Group Description	Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks. Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)	Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks. Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
Measure Participants	103	104
Number [participants]	5 4.9%	9 8.7%

2. Secondary Outcome

Title	Number of Participants With Cocaine Use
Time Frame	Week 3 - 9

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CPP-109 Vigabatrin Tablets	Placebo
Arm/Group Description	Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subject received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)	Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subject received Vigabatrin matching placebo tablets, bid, for 9 weeks Subject were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
Measure Participants	103	104
Week 3	95 92.2%	96 92.3%
Week 4	91 88.3%	95 91.3%
Week 5	88 85.4%	93 89.4%
Week 6	86 83.5%	90 86.5%
Week 7	84 81.6%	85 81.7%
Week 8	83 80.6%	82 78.8%
Week 9	81 78.6%	81 77.9%

Adverse Events

Arm/Group Title	CPP-109 Vigabatrin Tablets		Placebo
Arm/Group Description	Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.		Participants received Vigabatrin placebo table orally once daily for 7 weeks.
All Cause Mortality
	CPP-109 Vigabatrin Tablets		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	CPP-109 Vigabatrin Tablets		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/103 (5.8%)		3/104 (2.9%)
General disorders
Chest Pain	2/103 (1.9%)		1/104 (1%)
Investigations
Blood pressure increased	1/103 (1%)		0/104 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/103 (0%)		1/104 (1%)
Nervous system disorders
Loss of conciousness	1/103 (1%)		0/104 (0%)
Psychiatric disorders
Depression suicidal	0/103 (0%)		1/104 (1%)
Psychiatric symptom	1/103 (1%)		0/104 (0%)
Skin and subcutaneous tissue disorders
Eczema	1/103 (1%)		0/104 (0%)
Other (Not Including Serious) Adverse Events
	CPP-109 Vigabatrin Tablets		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	84/103 (81.6%)		89/104 (85.6%)
Eye disorders
Photopsia	11/103 (10.7%)		2/104 (1.9%)
Gastrointestinal disorders
Nausea	8/103 (7.8%)		25/104 (24%)
General disorders
Fatigue	16/103 (15.5%)		13/104 (12.5%)
Injury, poisoning and procedural complications
Contusion	3/103 (2.9%)		8/104 (7.7%)
Investigations
Blood pressure increased	8/103 (7.8%)		4/104 (3.8%)
Metabolism and nutrition disorders
Increased appetite	4/103 (3.9%)		3/104 (2.9%)
Musculoskeletal and connective tissue disorders
Back pain	8/103 (7.8%)		13/104 (12.5%)
Pain in extremity	11/103 (10.7%)		8/104 (7.7%)
Nervous system disorders
Headache	22/103 (21.4%)		29/104 (27.9%)
Psychiatric disorders
Insomnia	4/103 (3.9%)		8/104 (7.7%)
Renal and urinary disorders
Immune system disorders	4/103 (3.9%)		3/104 (2.9%)
Reproductive system and breast disorders
Dysmenorrhoea	1/103 (1%)		5/104 (4.8%)
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis	9/103 (8.7%)		7/104 (6.7%)
Skin and subcutaneous tissue disorders
Pruritus	5/103 (4.9%)		1/104 (1%)
Vascular disorders
Hypertension	4/103 (3.9%)		14/104 (13.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.