Methamphetamine DependencePhase 2NCT00730522
Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence
A Phase 2 study testing CPP-109 vigabatrin in people with Methamphetamine Dependence, run by Catalyst Pharmaceuticals, Inc. at 8 sites in United States.
Trial summary
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- CPP-109 vigabatrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2008to Nov 2009
- Phase
- Phase 2
- 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.
- Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for methamphetamine dependence as major diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
- Provides at least one urine specimen which is positive for methamphetamine according to a rapid screening test.
- Seeking treatment for methamphetamine dependence.
- Have normal visual fields.
- Be in generally good health based on history, physical examination and laboratory findings.
- If female of childbearing potential, use acceptable contraceptive methods
Who cannot join
- Has current dependence on any psychoactive substance other than methamphetamine, alcohol, nicotine, or cannabinoid or physiologic dependence on alcohol requiring medical detoxification.
- Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory values.
- Has history of serious cardiovascular reaction to methamphetamine.
- Has clinically significant cardiovascular impairment, abnormal ECG or uncontrolled hypertension.
- Be under court or other governmental agency (e.g. social services) mandate to obtain treatment or requiring outside urine monitoring.
- Be enrolled in an opiate substitution treatment program within 2 months of randomization.
Show all 12Show fewer
- Has ever taken vigabatrin in the past.
- Is pregnant or lactating.
- Has clinically significant ophthalmologic disease, which would preclude safety monitoring, is undergoing treatment for ocular disease or intends to have any ocular surgery or procedure performed during the time of their participation in the trial.
- Has received a drug with known major organ toxicity, including retinotoxicity.
- Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.
- Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Behavioral Health Research Center of the Southwest
Albuquerque, New Mexico
Pillar Research
Dallas, Texas
START Research and Treatment
Kansas City, Missouri
North County Clinical Research (NCCR)
Oceanside, California
Pahl Pharmaceutical Research
Oklahoma City, Oklahoma
Creighton University Medical Center
Omaha, Nebraska
South Bay Treatment Center
San Diego, California
Addiction Pharmacology Research Laboratory, St. Luke's Hospital
San Francisco, California
About this study
Official title: Vigabatrin for Treatment of Methamphetamine Dependence: A Phase II Study
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12).
Read the detailed description
This is a Phase II, randomized, double-blind, placebo-controlled, intent-to-treat, 2-arm, parallel design, multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction. The study will involve approximately 180 subjects (90/group) who meet DSM IV criteria for methamphetamine dependence. Subjects will be evaluated for their compliance with protocol inclusion/exclusion criteria during Screening/Baseline Phase, lasting up to 4 weeks.
At the conclusion of the Screening/Baseline Phase, subjects meeting all inclusion/exclusion criteria will be randomized to one of two treatment groups: vigabatrin or placebo. Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period. Subjects will be scheduled for clinic visits 3 times per week for efficacy and/or safety assessments during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects will return for follow up visits at Weeks 13, 16, 20 and 24.
- Conditions
- Methamphetamine Dependence
- Being tested
- CPP-109 vigabatrin, Matching Placebo
- Keywords
- Methamphetamine, Dependency, Addiction, vigabatrin
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPP-109 vigabatrinDrug
Also called GVG, gamma-vinyl GABA
tablets, bid for 12 weeks
Matching PlaceboDrug
tablets, bid, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | CPP-109 vigabatrin tablets Receives: Drug: CPP-109 vigabatrin |
| 2 | Placebo comparator | Matching Placebo Tablets Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12).
Measured: Weeks 11-12
Secondary outcomes (1)
• Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase.
Measured: Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionNov 2009
Why it stopped: To conserve remaining capital, Sponsor decided to terminate the study early.
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 Methamphetamine DependenceStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles W Gorodetzky, MD, PhD, Study director, Catalyst Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730522
- Sponsor's protocol ID
- CPP-02001
- Status last verified
- Oct 2020
- First submitted
- 5 Aug 2008
- Last updated
- 9 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vigabatrin for Treatment of Methamphetamine Dependence: A Phase II Study
- ClinicalTrials.gov ID
- NCT00730522
- Acronym / sponsor ID
- CPP-02001
- Conditions
- Methamphetamine Dependence
- Keywords
- Methamphetamine, Dependency, Addiction, vigabatrin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To conserve remaining capital, Sponsor decided to terminate the study early.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Catalyst Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 9 Dec 2020
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 study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12).
Detailed description
This is a Phase II, randomized, double-blind, placebo-controlled, intent-to-treat, 2-arm, parallel design, multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction. The study will involve approximately 180 subjects (90/group) who meet DSM IV criteria for methamphetamine dependence. Subjects will be evaluated for their compliance with protocol inclusion/exclusion criteria during Screening/Baseline Phase, lasting up to 4 weeks.
At the conclusion of the Screening/Baseline Phase, subjects meeting all inclusion/exclusion criteria will be randomized to one of two treatment groups: vigabatrin or placebo. Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period. Subjects will be scheduled for clinic visits 3 times per week for efficacy and/or safety assessments during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects will return for follow up visits at Weeks 13, 16, 20 and 24.
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 |
|---|---|---|
| 1 | Active comparator | Drug: CPP-109 vigabatrinCPP-109 vigabatrin tablets |
| 2 | Placebo comparator | Drug: Matching PlaceboMatching Placebo Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand the study and provide written informed consent.
- Male or female at least 18 years of age.
- Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for methamphetamine dependence as major diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
- Provides at least one urine specimen which is positive for methamphetamine according to a rapid screening test.
- Seeking treatment for methamphetamine dependence.
Key exclusion criteria (12 listed)
- Has current dependence on any psychoactive substance other than methamphetamine, alcohol, nicotine, or cannabinoid or physiologic dependence on alcohol requiring medical detoxification.
- Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory values.
- Has history of serious cardiovascular reaction to methamphetamine.
- Has clinically significant cardiovascular impairment, abnormal ECG or uncontrolled hypertension.
- Be under court or other governmental agency (e.g. social services) mandate to obtain treatment or requiring outside urine monitoring.
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 |
|---|---|---|
| CPP-109 vigabatrinAlso: GVG, gamma-vinyl GABAtablets, bid for 12 weeks | Drug | 1 |
| Matching Placebotablets, bid, 12 weeks | Drug | 2 |
Primary outcome
The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12).
Time frame: Weeks 11-12
1 secondary outcome
• Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase.
Time frame: Weeks 1-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charles W Gorodetzky, MD, PhD study director
Catalyst Pharmaceuticals, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPP-109 vigabatrin in people with Methamphetamine Dependence, run by Catalyst Pharmaceuticals, Inc. at 8 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 8 inclusion and 12 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: stopped early, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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.
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 9 Dec 2020). 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?
The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12). (time frame: Weeks 11-12). 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 9 Dec 2020.