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Cocaine DependencePhase 2NCT00527683

Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

A Phase 2 study testing Vigabatrin and Group therapy in people with Cocaine Dependence, run by NYU Langone Health at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Cocaine Dependence
What is being tested?
Vigabatrin and Group therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteMexico
Study dates
Apr 2007to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • In order to participate in the study, subjects must
  • Be at least 18 years of age and no older than 55 years of age.
  • Weigh more than 100 pounds.
  • Have a DSM-IV diagnosis of cocaine dependence.
  • Be seeking treatment for cocaine dependence.
  • Have a urine sample positive for qualitative cocaine toxicology at initial screening.
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  • Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
  • Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the Principal Investigator.
  • Have normal, or, if necessary, corrected visual acuity, visual fields, and normal fundoscopy findings

Who cannot join

  • In order to participate in the study, subjects must not:
  • Meet DSM-IV criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
  • Have neurological or psychiatric disorders such as: psychosis, bipolar illness, major depression, organic brain disease, dementia, any disorder which would require ongoing treatment or which would make study agent compliance difficult, history of suicide attempts assessed and/or current suicidal ideation/plan.
  • Have serious medical illnesses or other potentially life threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct.
  • Have a history of traumatic head injury.
  • Be mandated by a court to obtain treatment for cocaine dependence.
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  • Have been treated for cocaine addiction, or abstained from cocaine use for a significant period, within the 6 months preceding screening.
  • Be unable to complete the study protocol because of probable incarceration or relocation from the clinical area.
  • Have AIDS (although AIDS is an exclusion criterion, a positive antibody titer to HIV is not).
  • Have active syphilis that has not been treated or refuse treatment for syphilis
  • Have a history of neuroleptic malignant syndrome.
  • Have known or suspected hypersensitivity to vigabatrin or any other GABAergic drug.
  • Have received a drug with known potential for toxicity to a major organ system within 30 days prior to study entry (e.g., isoniazid, methotrexate).
  • Have participated in any experimental study within 4 weeks, or participated in any clinical trial utilizing vigabatrin.
  • Be pregnant or lactating.
  • Have any clinically significant abnormal laboratory value.
  • Have had electroconvulsive therapy with the 3 months preceding screening.
  • Have had any opiate-substitutes (methadone, LAAM, buprenorphine) within 2 months preceding screening.
  • Have a history of i.v. cocaine (or other psychoactive drug) use within 2 months preceding screening.
  • Have a current or past history of seizure disorder, including alcohol- or stimulant related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
  • Have a visual field defect, or factor predisposing to visual field defects, including glaucoma, severe myopia, retinal disorder, cataracts, diabetes or uncontrolled hypertension.
  • Have my illness, condition, and use of medications, in the opinion of the Principal Investigator and the admitting physician, which would preclude safe or successful completion of the study.
  • Be using vigabatrin or any medication that could interact adversely with vigabatrin administration, based on the longest time interval of A or B below:
  • A) Five half-lives of other medication or active metabolite(s), whichever is longer;
  • B) Two weeks.
  • Be lactose intolerant.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Clinica Integral de Tratamiento Contra las Adicciones SA de CV

    Mexico City, Mexico City, 11560

Other trials in Mexico

About this study

Official title: Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees

The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study.

Being tested
Vigabatrin, Placebo, Group therapy
Keywords
vigabatrin, GVG, addiction, treatment, cocaine dependence
Medical subject headings
Cocaine-Related Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VigabatrinDrug

    Also called Sabril, CPP 109, gamma vinyl GABA, GVG

    crystalline drug dissolved in orange juice, dosage escalates from 500 mg twice daily to 1.5 g twice daily over a 3 week period. This dose is maintained for 4 weeks and then tapered to zero over the next two weeks

  • PlaceboDrug

    orange juice is administered twice daily in containers indistinguishable from the treatment arm.

  • Group therapyBehavioural

    Participants attend group sessions once a week

Study groups in NCT00527683
Study groupRoleWhat they receive
AActive comparatorSubjects will receive vigabatrin in escalating doses to 3 grams per day over three weeks, continued for 4 weeks and then tapered to zero over the next 2 weeks.
Receives: Drug: Vigabatrin; Behavioral: Group therapy
BPlacebo comparatorOrange juice and administration identical to Arm A.
Receives: Drug: Placebo; Behavioral: Group therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed).

    Measured: These must be the last three weeks (7,8,9) of the trial.

Secondary outcomes (2)

  1. 3 consecutive weeks of negative urines (one slip allowed)

    Measured: Last 3 weeks (7,8,9) of the trial

  2. cocaine craving

    Measured: Weeks 1, 5,9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionNov 2007
  4. Study completionNov 2007

Resources

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
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00527683
Sponsor's protocol ID
H06-152
Status last verified
Apr 2008
First submitted
10 Sep 2007
Last updated
11 Apr 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Fechtner RD, Khouri AS, Figueroa E, Ramirez M, Federico M, Dewey SL, Brodie JD. Short-term treatment of cocaine and/or methamphetamine abuse with vigabatrin: ocular safety pilot results. Arch Ophthalmol. 2006 Sep;124(9):1257-62. doi: 10.1001/archopht.124.9.1257.

    PubMed 16966620

  • Brodie JD, Figueroa E, Laska EM, Dewey SL. Safety and efficacy of gamma-vinyl GABA (GVG) for the treatment of methamphetamine and/or cocaine addiction. Synapse. 2005 Feb;55(2):122-5. doi: 10.1002/syn.20097.

    PubMed 15543630

  • Brodie JD, Figueroa E, Dewey SL. Treating cocaine addiction: from preclinical to clinical trial experience with gamma-vinyl GABA. Synapse. 2003 Dec 1;50(3):261-5. doi: 10.1002/syn.10278. No abstract available.

    PubMed 14515344

  • Brodie JD, Case BG, Figueroa E, Dewey SL, Robinson JA, Wanderling JA, Laska EM. Randomized, double-blind, placebo-controlled trial of vigabatrin for the treatment of cocaine dependence in Mexican parolees. Am J Psychiatry. 2009 Nov;166(11):1269-77. doi: 10.1176/appi.ajp.2009.08121811. Epub 2009 Aug 3.

    PubMed 19651710

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vigabatrin and Group therapy in people with Cocaine Dependence, run by NYU Langone Health at 1 site in Mexico.

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 9 inclusion and 26 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 11 Apr 2008. 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 Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (time frame: These must be the last three weeks (7,8,9) of the trial.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00527683, which also lists 4 linked publications.

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 11 Apr 2008.

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