Methamphetamine AddictionPhase 1NCT00506935
Assessment of GVG for the Treatment of Methamphetamine Dependence
A Phase 1 study testing GVG in people with Methamphetamine Addiction, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to find out if GVG can reduce drug use and determine safety and effects of GVG when used together with methamphetamine. This study involves staying in the hospital for 21 days. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Addiction
- What is being tested?
- GVG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2008
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be English-speaking volunteers who are not seeking treatment at the time of the study;
- Be between 18-55 years of age;
- Meet DSM-IV TR criteria for MA abuse or dependence;
- Have a self-reported history of using MA by the smoked or IV route, for at least 2 years.
- Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 85-150mm Hg systolic and 45-90mm Hg diastolic; this criterion must be met within 2 days of admission.
- Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal;
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- Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias;
- Be able to fully cooperate with visual field testing to the point that a valid test is obtained during screening/baseline.
- In the judgment of the study ophthalmologist, have visual fields within normal limits for age during the screening/baseline measurements;
- Have acceptable ERG results for initiation of treatment with GVG (in the judgment of Drs. Nusinowitz and Newton, with ophthalmologic consultation as needed) , including having a value of the 30 Hz Flicker a-b amplitude as measured during the screening/baseline electroretinogram evaluations of 52 μV or above;
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.
Who cannot join
- Have any history or evidence suggestive of seizure disorder or brain injury;
- Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure;
- Have neurological or psychiatric disorders, such as:
- psychosis, bipolar illness or major depression as assessed by the MINI;
- organic brain disease or dementia assessed by clinical interview;
- history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult;
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- history of suicide attempts within the past three months assessed by the MINI and/or current suicidal ideation/plan as assessed by the MINI;
- Have evidence of clinically significant heart disease or hypertension, as determined by the PI;
- Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by the PI;
- Have any ophthalmologic disorder (e.g., glaucoma, cataracts, optic nerve disease, fixation problems, etc.) which, in the judgment of the study ophthalmologist, would:
- make it difficult to obtain valid ophthalmologic perimetry, or electroretinography (ERG) assessments, or
- increase the risks of visual side effects associated with VGB.
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease;
- Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication;
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation;
- Have any history of asthma, chronic coughing and wheezing, or other respiratory illnesses;
- Currently use alpha or beta agonists, theophylline, or other sympathomimetics;
- Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study of Vigabatrin (GVG) for Methamphetamine Dependence
The purpose of this study is to find out if GVG can reduce drug use and determine safety and effects of GVG when used together with methamphetamine. This study involves staying in the hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount if methamphetamine will be injected on some study days. This study will enroll people that use methamphetamine. Participants will be compensated.
- Conditions
- Methamphetamine Addiction
- Being tested
- GVG, placebo
- Keywords
- methamphetamine, GVG, vigabatrin, stimulant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GVGDrug
Also called vigabatrin
5 grams GVG
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GVG Receives: Drug: GVG |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AddictionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Thomas Newton, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506935
- Sponsor's protocol ID
- #05-10-091-01
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2007
- Last updated
- 13 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Vigabatrin (GVG) for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00506935
- Acronym / sponsor ID
- #05-10-091-01
- Conditions
- Methamphetamine Addiction
- Keywords
- methamphetamine, GVG, vigabatrin, stimulant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 25 Jul 2007 (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.
The purpose of this study is to find out if GVG can reduce drug use and determine safety and effects of GVG when used together with methamphetamine. This study involves staying in the hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount if methamphetamine will be injected on some study days. This study will enroll people that use methamphetamine. Participants will be compensated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GVGGVG |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Be English-speaking volunteers who are not seeking treatment at the time of the study;
- Be between 18-55 years of age;
- Meet DSM-IV TR criteria for MA abuse or dependence;
- Have a self-reported history of using MA by the smoked or IV route, for at least 2 years.
- Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 85-150mm Hg systolic and 45-90mm Hg diastolic; this criterion must be met within 2 days of admission.
Key exclusion criteria (18 listed)
- Have any history or evidence suggestive of seizure disorder or brain injury;
- Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure;
- Have neurological or psychiatric disorders, such as:
- Have evidence of clinically significant heart disease or hypertension, as determined by the PI;
- Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by the PI;
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 |
|---|---|---|
| GVGAlso: vigabatrin5 grams GVG | Drug | 1 |
| placeboplacebo | Drug | 2 |
Primary outcome
Not reported in the source record.
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 13 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 GVG in people with Methamphetamine Addiction, run by Baylor College of Medicine 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 11 inclusion and 18 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 13 Jul 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.
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 13 Jul 2017.