AlcoholismPhase 2VGBNCT01335867
Vigabatrin for Cocaine and Alcohol Dependence
A Phase 2 study testing Vigabatrin in people with Alcoholism and Cocaine Dependence, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism, 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- 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
- Male and females, 18 years of age or older.
- Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID-IV.
- Used cocaine in the past 30 days and used no less than $200 of cocaine in a consecutive 30 day period over the 90 day period prior to intake. Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell 1995) a drank within 30 days of intake day, b. reports a minimum of 48 standard alcoholic (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as greater than 4 drinks per day in males and greater than 3 drinks per day in females) in this same pre-treatment period.
- Three consecutive days of abstinence from alcohol directly prior to the day of randomization, determined by self-reports and confirmed by negative breathalyzer tests, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan and Sellers 1989) score below eight. Subjects will be given 2 additional weeks beyond the screening week to attain the appropriate period of alcohol abstinence prior to randomization.
- Have a verifiable address of principal residence, lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
- Speaks, understands, and prints in English
- Ability to give informed consent
Who cannot join
- Meets DSM IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis), determined by the SCID. Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of diphenhydramine used sparingly, if necessary, for sleep).
- Meets current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation as determined by the principal investigator.
- Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
- Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated total bilirubin levels (>1.3 mg/dl), or elevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT). Patients with Gilberts Syndrome will not be excluded.
- Use of an investigational medication in the 30 days prior to randomization.
- History of prior treatment with vigabatrin
Show all 9Show fewer
- History of prior treatment with drugs with known retinotoxicity
- History of visual field defects or predisposing factors, including glaucoma, severe myopia, retinal disorders, cataracts, diabetes, or uncontrolled hypertension.
- Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, female condom), intrauterine progesterone contraceptive system, levonorgrestrel implant, and medroxyprogesterone acetate contraceptive injection, copper IUD, vaginal contraceptive film, cervical cap, contraceptive foam, hormonal vaginal contraceptive ring (NuvaRing®) or oral contraceptives.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Vigabatrin for the Treatment of Cocaine and Alcohol Dependence
The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
Read the detailed description
The hypotheses in the proposed study will be tested with a 2-group design to assess the efficacy of vigabatrin compared to placebo. We will follow NIAAA's COMBINE Medical Management (MM) manual in weekly dispensing medications, safety checks and medication adherence. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 60 men and women with current DSM-IV diagnoses of both cocaine and alcohol dependence who will be randomized to vigabatrin or placebo (30 subjects per group). All subjects will receive weekly sessions of CBT. The study length for each subject is comprised of a1-3 weeks of screening and baseline evaluations, an 8-week double-blind, placebo-controlled trial with CBT (medication phase), and one follow-up visit 12 weeks after starting study medication.
Study medication will be initiated in Week 2. The research physician will explain the dosing regimen and subjects will be randomly assigned to receive either vigabatrin or identical placebo tablets. Subjects will receive 1 gram of vigabatrin or identical placebo tablets on medication days 1-3 then 1.5 grams or identical placebo tablets on days 4-7. The dose ids increased to 2 grams in week 2, 3 grams in weeks 4-7 and then reduced to 2 grams days 50-53, and to 1 gram on days 54-56
- Conditions
- Alcoholism, Cocaine Dependence
- Being tested
- Vigabatrin, Placebo
- Medical subject headings
- Alcoholism, 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 Sabril
Vigabatrin escalated to 3 grams daily for 8 weeks
PlaceboDrug
Also called placebo vigabatrin
Placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Vigabatrin | Experimental | Vigabatrin titrated to 3 grams daily for 8 weeks Receives: Drug: Vigabatrin |
| Placebo | Placebo comparator | Identical placebo daily for three weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Reduction in Cocaine Use
The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.
Measured: last 3 weeks of the trial
Proportion of Heavy Drinking Days
The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.
Measured: 8 weeks
Secondary outcomes (3)
Measures of Cocaine Craving
Measures of cocaine craving at the end of the trial will be measured using the Brief Substance Craving Ccale. Craving intensity + Craving frequency + Craving Duration each measured on a 4 point scale. Sum of the three scales was overall craving composite. Higher numbers meaning greater craving. Maximum score 12 minimum 0.
Measured: 8 weeks
Disease Severity and Improvement
Number of subjects in each group rated as improved or very much improved at the end of the trial
Measured: 8 weeks
Cocaine Withdrawal Severity
Measure of cocaine withdrawal severity will include Cocaine Selective Severity Assessment scores. Minimum score is 0 Maximum score is 119 Higher score is indicative of worse cocaine withdrawal symptoms.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionDec 2013
Why it stopped: interim analysis of efficacy completed and termination recommended
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 AlcoholismStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kyle M Kampman, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335867
- Sponsor's protocol ID
- 812864
- Other IDs
- P50DA012756
- Acronym
- VGB
- Status last verified
- Sep 2019
- First submitted
- 13 Apr 2011
- Last updated
- 6 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Vigabatrin for the Treatment of Cocaine and Alcohol Dependence
- ClinicalTrials.gov ID
- NCT01335867
- Acronym / sponsor ID
- VGB / 812864
- Conditions
- Alcoholism, Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis of efficacy completed and termination recommended
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Posted 12 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
Detailed description
The hypotheses in the proposed study will be tested with a 2-group design to assess the efficacy of vigabatrin compared to placebo. We will follow NIAAA's COMBINE Medical Management (MM) manual in weekly dispensing medications, safety checks and medication adherence. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 60 men and women with current DSM-IV diagnoses of both cocaine and alcohol dependence who will be randomized to vigabatrin or placebo (30 subjects per group). All subjects will receive weekly sessions of CBT. The study length for each subject is comprised of a1-3 weeks of screening and baseline evaluations, an 8-week double-blind, placebo-controlled trial with CBT (medication phase), and one follow-up visit 12 weeks after starting study medication.
Study medication will be initiated in Week 2. The research physician will explain the dosing regimen and subjects will be randomly assigned to receive either vigabatrin or identical placebo tablets. Subjects will receive 1 gram of vigabatrin or identical placebo tablets on medication days 1-3 then 1.5 grams or identical placebo tablets on days 4-7. The dose ids increased to 2 grams in week 2, 3 grams in weeks 4-7 and then reduced to 2 grams days 50-53, and to 1 gram on days 54-56
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 |
|---|---|---|
| Vigabatrin | Experimental | Drug: VigabatrinVigabatrin titrated to 3 grams daily for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIdentical placebo daily for three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and females, 18 years of age or older.
- Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID-IV.
- Used cocaine in the past 30 days and used no less than $200 of cocaine in a consecutive 30 day period over the 90 day period prior to intake. Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell 1995) a drank within 30 days of intake day, b. reports a minimum of 48 standard alcoholic (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as greater than 4 drinks per day in males and greater than 3 drinks per day in females) in this same pre-treatment period.
- Three consecutive days of abstinence from alcohol directly prior to the day of randomization, determined by self-reports and confirmed by negative breathalyzer tests, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan and Sellers 1989) score below eight. Subjects will be given 2 additional weeks beyond the screening week to attain the appropriate period of alcohol abstinence prior to randomization.
- Have a verifiable address of principal residence, lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
Key exclusion criteria (9 listed)
- Meets DSM IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis), determined by the SCID. Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of diphenhydramine used sparingly, if necessary, for sleep).
- Meets current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation as determined by the principal investigator.
- Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
- Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated total bilirubin levels (>1.3 mg/dl), or elevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT). Patients with Gilberts Syndrome will not be excluded.
- Use of an investigational medication in the 30 days prior to randomization.
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: SabrilVigabatrin escalated to 3 grams daily for 8 weeks | Drug | Vigabatrin |
| PlaceboAlso: placebo vigabatrinPlacebo pills | Drug | Placebo |
Primary outcome
Number of Participants With a Reduction in Cocaine Use
Time frame: last 3 weeks of the trial
The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.
Proportion of Heavy Drinking Days
Time frame: 8 weeks
The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.
3 secondary outcomes
Measures of Cocaine Craving
Time frame: 8 weeks
Disease Severity and Improvement
Time frame: 8 weeks
Cocaine Withdrawal Severity
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Pennsylvania Center for Studies of AddictionsLink provided by the sponsor.
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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.
Kyle M Kampman, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vigabatrin in people with Alcoholism and Cocaine Dependence, run by University of Pennsylvania at 1 site 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 9 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 Jun 2015). 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?
Number of Participants With a Reduction in Cocaine Use (time frame: last 3 weeks of the trial). The study lists 2 primary outcomes in all. 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 6 Sep 2019.