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The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified placebo-controlled experimental design.
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, 80-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 tiagabine, sertraline, and donepzil. Tiagabine is hypothesized to interfere with glutamatergic cocaine mechanisms relevant to addiction. Sertraline is a potent and selective inhibitor of neuronal 5-HT reuptake, which may modulate the reinforcing and cueing effects of cocaine. Donepezil is hypothesized to interfere with cholinergic cocaine mechanisms relevant to addiction.
Control: Placebo Control, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
National Institute on Drug Abuse (NIDA)
Published on BioPortfolio: 2014-07-23T21:56:00-0400
To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertralin...
The purpose of this study is to evaluate the effects of buprenorpine on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate d...
The purpose of this study is to evaluate the effects of pergolide on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving in non-opiate depe...
To study of classical conditioning mechanisms associated with arousal, craving and cocaine use.
The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocain...
Depressive symptoms may contribute to cocaine use. However, tests of the relationship between depression and severity of cocaine use have produced mixed results, possibly due to heterogeneity in indiv...
Although behavioral treatment for cocaine use disorders is common, the use of cognitive neuroscience methods to investigate these treatments' mechanisms of action remains limited. Cognitive control (e...
The purpose of the present study was to test the efficacy of sertraline and Interpersonal Psychotherapy (IPT) relative to pill placebo in a two site randomized controlled trial over a period of 12 wee...
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Attention-deficit hyperactivity disorder (ADHD) is overrepresented among individuals seeking treatment for substance use disorders. We previously reported that treatment with extended release mixed am...
Disorders related or resulting from use of cocaine.
These disorders are related to both SCHIZOPHRENIA SPECTRUM AND RELATED DISORDERS and DEPRESSIVE DISORDERS in terms of symptomatology, family history, and genetics. (DSM-V) .
The purified, alkaloidal, extra-potent form of cocaine. It is smoked (free-based), injected intravenously, and orally ingested. Use of crack results in alterations in function of the cardiovascular system, the autonomic nervous system, the central nervous system, and the gastrointestinal system. The slang term "crack" was derived from the crackling sound made upon igniting of this form of cocaine for smoking.
Disorders related to substance abuse, the side effects of a medication, toxin exposure, and ALCOHOL-RELATED DISORDERS.
SMOKING of COCAINE.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...