Cocaine-Related Disorders Clinical Trial
Official title:
CREST-I: Resperine, Gabapentin, or Lamotrigine vs. Placebo
The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the treatment of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo control.
Considerable progress in preclinical research has provided a basis for hypothesis driven
clinical trials in cocaine dependence. A greater mechanistic understanding of both cocaine
and many clinically approved medications has led to the identification of many promising
medications for the treatment of cocaine dependence.
For this reason NIDA has developed a CREST (Clinical Rapid Evaluation Screening Trial)
protocol to provide a needed incremental medication screening step between preclinical
research and full blown expensive Phase III pivotal trials. While patients receive manual
based psychotherapy, three medications are screened compared to unmatched placebo in an
eight-week, 60-subject, four cell design trial. Other important features of the CREST
protocol include collecting baseline measurements over a two week period and analyzing
primary outcome measures (quantitative urine toxicology and clinical global improvement
scales) in terms of a composite score of overall individual patient improvement.
The three medications being evaluated in this trial include reserpine, gabapentin and
lamotrigine. Reserpine is being screened because of its well-known preclinical ability to
functionally antagonize cocaine (by depleting neurochemicals elevated by cocaine).
Gabapentin and lamotrigine are hypothesized to interfere with glutamatergic cocaine
sensitization/kindling mechanisms relevant to addiction.
;
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01526538 -
Improving Learning-based Treatment of Cocaine Dependence With Medication
|
Phase 2 | |
| Completed |
NCT00877435 -
Prize Reinforcement Contingency Management for Cocaine Dependence: a 24-week Randomized Controlled Trial
|
N/A | |
| Completed |
NCT00430690 -
Acoustic Startle Reduction In Cocaine Dependence
|
||
| Completed |
NCT00217997 -
Impulsivity, Brain Function, and Substance Abuse Treatment in Cocaine Dependent Individuals
|
N/A | |
| Active, not recruiting |
NCT00094315 -
Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1
|
Phase 1 | |
| Terminated |
NCT00142883 -
The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3
|
N/A | |
| Completed |
NCT00218348 -
Treatment of Cocaine Dependence: Comparison of Three Doses of Dextro-Amphetamine Sulfate and Placebo
|
Phase 2 | |
| Completed |
NCT00142844 -
Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1
|
Phase 2 | |
| Completed |
NCT00158132 -
Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2
|
Phase 2 | |
| Completed |
NCT00015054 -
Methylphendidate Treatment of Cocaine Dependent Patients With Attention Deficit Hyperactivity Disorder - 3
|
Phase 2 | |
| Completed |
NCT00000294 -
Effects of Carvedilol on Cocaine Use in Humans - 11
|
Phase 2 | |
| Completed |
NCT00000308 -
Dextroamphetamine-Cocaine Behavioral Intervention - 5
|
Phase 2 | |
| Completed |
NCT00000314 -
M-CPP and Fenfluramine in Cocaine Addicts - 3
|
Phase 2 | |
| Completed |
NCT00000280 -
Glutaminergic Agents for Cocaine Abuse - 5
|
Phase 1 | |
| Terminated |
NCT00000276 -
Dopamine Reuptake Inhibitors of Cocaine Abuse - 1
|
Phase 1 | |
| Completed |
NCT00000188 -
Selegiline in Treatment of Cocaine Dependence - 2
|
Phase 2 | |
| Completed |
NCT00000278 -
Disulfiram for Cocaine-Alcohol Abuse - 3
|
Phase 2 | |
| Completed |
NCT00000281 -
Pharmacotherapy for Schizophrenic Drug Users - 6
|
Phase 2 | |
| Completed |
NCT00000277 -
Mazindol for Cocaine Abuse - 2
|
Phase 2 | |
| Completed |
NCT00000306 -
Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
|
Phase 2 |