| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21224 |
| Conditions: |
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Cocaine Dependence |
| Purpose: |
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This is an outpatient clinical trial of topiramate for addressing cocaine dependence and
reduction of cocaine associated behaviors in opiate dependent drug users maintained on
methadone treatment.
The study aims to answer whether topiramate
1. is safe and acceptable to methadone patients
2. reduces cocaine use
3. helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD
and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive
performance.
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| Study summary: |
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This is an outpatient clinical trial of topiramate treatment for cocaine dependence and
reduction of cocaine-associated HIV risk behavior. Topiramate is of high current interest
in this regard, having been identified my NIDA leadership as among only a small number of
tested candidates providing a "positive signal" and warranting further clinical
investigation (Vocci, 2005). Topiramate is a marketed antiepileptic that enhances the
GABAergic system and antagonizes the glutamatergic system, both new targets in the search
for anti-cocaine treatments. A published pilot trial has supported topiramate's efficacy,
and it is especially intriguing as potentially beneficial against other disorders prevalent
among drug users, such as mood, anxiety, panic disorders, PTSD, pain and cognitive
dysfunction, that may contribute to drug use. Design/Methods: This is phase II,
double-blind randomized (stratified) 4 group, 2x2 design, evaluating topiramate versus
placebo under each of two levels of cocaine-abstinence motivation --
cocaine-abstinence-contingent versus non-contingent voucher incentives. Conduct will be in a
methadone maintenance context to ensure adequate retention and adherence, with participants
dually dependent on opioids and cocaine. The target topiramate stabilization dose is 300
mg/day (150 mg b.i.d.), with one dose per day being observed at the clinic. The
voucher-incentive manipulation provides valuable information about the role of motivation in
modulating medication effects; it also provides a positive control condition to document the
sensitivity of the study methods for detecting therapeutic benefit. Enrollment will be 300
patients ( 240 completers, 60/group). Participation will be up to 33 weeks -
Baseline/Placebo-Run-in (5 weeks), Randomized Medication Treatment (20 weeks, induction,
stable dosing, taper), Randomized Voucher Treatment (12 weeks, embedded in Medication
period), and Therapeutic Disposition (up to 8 weeks). Data analysis focuses on the 8-week
period of stable dosing and concurrent vouchers. The primary outcome variable is days
abstinent from cocaine, as determined by a combination of self-report and objective
confirmation by quantitative urinalysis toxicology of cocaine metabolite levels and
application of the "Preston" rule for determining abstinence. Secondary outcome variables
are measures of adverse behaviors and symptoms commonly co-occurring in cocaine abusers
(alcohol abuse, tobacco use, depression, anxiety, PTSD, pain, neuro-cognitive and
psychomotor performance dysfunction) that may contribute to drug use and/or detrimental
effects. Significance: This randomized controlled clinical trial will provide valuable
information about the actions and therapeutic effectiveness of the promising candidate
anti-cocaine pharmacotherapy topiramate, and about the conditions, correlates, and
modulators of any observed effectiveness. It will also provide valuable methodological
information contributing to the continuing evolution of clinical trial methods for
evaluating potential drug abuse treatment medications. |
| Criteria: |
|
Inclusion Criteria:
- 18 - 55 years old
- active opioid and cocaine dependence
- seeking treatment for cocaine and opioid dependence
- eligible for methadone maintenance per state and federal regulations
- able and willing to provide a urine sample thrice a week
- willing to answer questionnaires on a weekly basis
- willing to provide breath samples for presence of alcohol thrice weekly
- fluent in the English language
Exclusion Criteria:
- allergy to sulfonamide drugs
- diabetes, respiratory insufficiency, renal tubular acidosis, renal insufficiency,
heart failure, liver insufficiency, chronic diarrhea, other chronic diseases
predisposing to a risk of acidosis
- history of nephrolithiasis
- HIV positive individuals who meet AIDS criteria by CDC criteria or are taking
antiretroviral medications
- serious psychiatric illness (psychosis, dementia)
- glaucoma or family history of glaucoma
- prostate hyperplasia, shy bladder, irritable bladder, difficulty providing urine
samples on demand
- female participants: being pregnant, lactating, or unwilling to use an effective
method of contraception
- use of antiepileptic agents
- benzodiazepine dependence
- latex allergy |
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| Study is available at: |
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Behavioral Pharmacology Research Unit
Baltimore, MD 21224
United States
Primary Contact:
Toran Claireborne, BA
Phone: 410-550-1102 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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