Cocaine AddictionPhase 2/3NCT01281202
Vigabatrin for the Treatment of Cocaine Dependency
A Phase 2/3 study testing Vigabatrin in people with Cocaine Addiction and Cocaine Dependence, run by Catalyst Pharmaceuticals, Inc. at 13 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Addiction, Cocaine Dependence
- What is being tested?
- Vigabatrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 13 sitesUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Please contact site for more information
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Pacific Institute for Research and Evaluation
Albuquerque, New Mexico, 87102
Mountain Manor Treatment Center @ Baltimore
Baltimore, Maryland, 21229
Boston University School of Medicine
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29403
Pillar Clinical Research, LLC
Dallas, Texas, 75243
VA Medical Center
Denver, Colorado, 80220
University of Texas Health Science Center at Houston
Houston, Texas, 77054
Matrix Institute on Addictions
Los Angeles, California, 90016
University of Miami School of Medicine
Miami, Florida, 33136
NeuroPsychiatric Research & Practice Assoc., Ltd.
Oak Brook, Illinois, 60523
Western Psychiatric Inst. and Clinic
Pittsburgh, Pennsylvania, 15213
George E Wahlen VA Medical Center
Salt Lake City, Utah, 84148
Friends Research Institute
Torrance, California, 90502
About this study
Official title: Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
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.
Read the 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.
- Conditions
- Cocaine Addiction, Cocaine Dependence
- Being tested
- Vigabatrin, Matching Placebo
- Keywords
- Cocaine, Cocaine Addiction Treatment, Cocaine Treatment, Vigabatrin, CPP-109, Catalyst, National Institute on Drug Abuse
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VigabatrinDrug
Also called CPP-109, GVG, VGB
Tablets
Matching PlaceboDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| CPP-109 Vigabatrin Tablets | Active comparator | 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) Receives: Drug: Vigabatrin |
| Placebo | Placebo comparator | 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) Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Weeks 8-9
Secondary outcomes (1)
Number of Participants With Cocaine Use
Measured: Week 3 - 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Kathleen Brady, MD, PhD, Principal investigator, Medical University of South CarolinaChristopher J Stock, PharmD, Study chair, George E. Wahlen VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281202
- Sponsor's protocol ID
- CPP-01005/CS# 1030 TRANSFERRED
- Other IDs
- Y1-DA4006
- Status last verified
- May 2016
- First submitted
- 20 Jan 2011
- Last updated
- 18 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
- ClinicalTrials.gov ID
- NCT01281202
- Acronym / sponsor ID
- CPP-01005/CS# 1030 TRANSFERRED
- Conditions
- Cocaine Addiction, Cocaine Dependence
- Keywords
- Cocaine, Cocaine Addiction Treatment, Cocaine Treatment, Vigabatrin, CPP-109, Catalyst, National Institute on Drug Abuse
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), VA Office of Research and Development
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 23 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPP-109 Vigabatrin Tablets | Active comparator | Drug: VigabatrinSubjects 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) |
| Placebo | Placebo comparator | Drug: Matching PlaceboSubjects 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- Please contact site for more information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VigabatrinAlso: CPP-109, GVG, VGBTablets | Drug | CPP-109 Vigabatrin Tablets |
| Matching PlaceboTablets | Drug | Placebo |
Primary outcome
Abstinence
Time frame: 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).
1 secondary outcome
Number of Participants With Cocaine Use
Time frame: Week 3 - 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Brady, MD, PhD principal investigator
Medical University of South Carolina
Christopher J Stock, PharmD study chair
George E. Wahlen VA Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vigabatrin in people with Cocaine Addiction and Cocaine Dependence, run by Catalyst Pharmaceuticals, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence (time frame: Weeks 8-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.