Cocaine AddictionPhase 1NCT00626834
Vigabatrin Ph 1 Cocaine Interaction Study
A Phase 1 study testing Vigabatrin in people with Cocaine Addiction, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
This is a Phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine Addiction
- What is being tested?
- Vigabatrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 2010
- Phase
- Phase 1
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be between 18 and 45 years of age, inclusive
- Currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine
- Able to provide written informed consent
- A negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine
Who cannot join
- Please contact site for more information.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study
This is a Phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions.
Read the detailed description
STUDY DESIGN: This is a randomized, double-blind, placebo-controlled, parallel group study of the effects of VGB compared to placebo control on the physiological and subjective effects of IV infusions of cocaine (cocaine experienced volunteers).
Subjects will be randomized within each clinical site to one of four groups (placebo control or one of three doses of VGB twice daily).During VGB steady state dosing, subjects will receive double-blind infusions of saline and cocaine. Subjects will be asked to return for follow-up approximately 7 and 14 days after the day of clinic discharge.
STUDY DURATION: The maximum duration is 56 days, including 14 inpatient days of assessments and investigational products administration, and two follow-up visits after clinic discharge.
SAMPLE SIZE: Twenty-four subjects will be randomized to one of three doses of vigabatrin or placebo.
POPULATION: Volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45 years of age.
- Conditions
- Cocaine Addiction
- Being tested
- Vigabatrin, Matching placebo
- Keywords
- cocaine addiction, vigabatrin, ovation pharmaceuticals, cocaine, cocaine related disorders, behavior addictive, mental disorders, therapeutic uses, physiologic effects of drugs, disorder of environmental origin, central nervous system stimulants, central nervous system agents, pharmacological actions, substance related disorders
- Medical subject headings
- Cocaine-Related Disorders, Behavior, Addictive, Mental Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VigabatrinDrug
Dose 1 BID
VigabatrinDrug
Dose 2 BID
VigabatrinDrug
Dose 3 BID
Matching placeboDrug
Matching placebo BID
| Study group | Role | What they receive |
|---|---|---|
| Vigabatrin Dose 1 | Experimental | Not described Receives: Drug: Vigabatrin |
| Vigabatrin Dose 2 | Experimental | Not described Receives: Drug: Vigabatrin |
| Vigabatrin Dose 3 | Experimental | Not described Receives: Drug: Vigabatrin |
| Matching placebo | Placebo comparator | Not described Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety/tolerability and AE assessments including HR/BP/ECG/QTc
Measured: 56 days
Secondary outcomes (1)
VGB/PK during cocaine infusions and effect of VGB on cocaine craving
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John D. Roache, Ph.D., Principal investigator, University of TexasNora Chiang, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)Ahmed Elkashef, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)Roberta Kahn, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626834
- Sponsor's protocol ID
- OV-1014
- Status last verified
- Aug 2016
- First submitted
- 18 Feb 2008
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study
- ClinicalTrials.gov ID
- NCT00626834
- Acronym / sponsor ID
- OV-1014
- Conditions
- Cocaine Addiction
- Keywords
- cocaine addiction, vigabatrin, ovation pharmaceuticals, cocaine, cocaine related disorders, behavior addictive, mental disorders, therapeutic uses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Feb 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions.
Detailed description
STUDY DESIGN: This is a randomized, double-blind, placebo-controlled, parallel group study of the effects of VGB compared to placebo control on the physiological and subjective effects of IV infusions of cocaine (cocaine experienced volunteers).
Subjects will be randomized within each clinical site to one of four groups (placebo control or one of three doses of VGB twice daily).During VGB steady state dosing, subjects will receive double-blind infusions of saline and cocaine. Subjects will be asked to return for follow-up approximately 7 and 14 days after the day of clinic discharge.
STUDY DURATION: The maximum duration is 56 days, including 14 inpatient days of assessments and investigational products administration, and two follow-up visits after clinic discharge.
SAMPLE SIZE: Twenty-four subjects will be randomized to one of three doses of vigabatrin or placebo.
POPULATION: Volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45 years of age.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vigabatrin Dose 1 | Experimental | Drug: Vigabatrin |
| Vigabatrin Dose 2 | Experimental | Drug: Vigabatrin |
| Vigabatrin Dose 3 | Experimental | Drug: Vigabatrin |
| Matching placebo | Placebo comparator | Drug: Matching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between 18 and 45 years of age, inclusive
- Currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine
- Able to provide written informed consent
- A negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine
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 |
|---|---|---|
| VigabatrinDose 1 BID | Drug | Vigabatrin Dose 1 |
| VigabatrinDose 2 BID | Drug | Vigabatrin Dose 2 |
| VigabatrinDose 3 BID | Drug | Vigabatrin Dose 3 |
| Matching placeboMatching placebo BID | Drug | Matching placebo |
Primary outcome
safety/tolerability and AE assessments including HR/BP/ECG/QTc
Time frame: 56 days
1 secondary outcome
VGB/PK during cocaine infusions and effect of VGB on cocaine craving
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No
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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.
John D. Roache, Ph.D. principal investigator
University of Texas
Nora Chiang, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
Ahmed Elkashef, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vigabatrin in people with Cocaine Addiction, run by National Institute on Drug Abuse (NIDA) 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 4 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 12 Jan 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
safety/tolerability and AE assessments including HR/BP/ECG/QTc (time frame: 56 days). 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 12 Jan 2017.