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Early Phase II Trials for Cocaine Medication Development - 1

2014-08-27 04:00:12 | BioPortfolio

Summary

The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents.

The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This

Description

This was an 18-week prospective, randomized, placebo-controlled crossover design with placebo lead-in phase and terminal placebo phase. After two weeks of single-blind placebo, patients were randomly assigned to one of two schedules of medication:

2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo Group 2 placebo placebo risperidone placebo

The first 6-week phase provided an initial double-blind medication-placebo comparison. In the second six-week phase (weeks 7-12), patients crossed over to the opposite treatment. During weeks 13-18, Group 1 patients remained on placebo while Group 2 patients were tapered from risperidone to placebo. For six weeks after the end of the trial, patients were offered routine clinical treatment with counseling and psychiatrist visits as needed. Medication dosage was titrated upwards on a fixed-flexible schedule to a maximum dose of 4 mg per day. Medication began at ½ mg risperidone for 3 days, then 1 mg for four days, 2 mg per day during week 2, 3 mg per day during week 3, and 4 mg per day during weeks 4-6. The titration schedule for risperidone in weeks 7-12 was the same as for weeks 1-6. In addition to treatment as usual, patients received a modified manual-guided relapse prevention counseling program in weekly meetings lasting approximately 20 minutes; these sessions provided cognitive and behavioral skills that were found to be helpful to patients in reducing cocaine use.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Cocaine-Related Disorders

Intervention

Risperidone, Placebo

Location

Research Foundation for Mental Hygiene
New York
New York
United States
10032

Status

Completed

Source

National Institute on Drug Abuse (NIDA)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:12-0400

Clinical Trials [1212 Associated Clinical Trials listed on BioPortfolio]

Infusion Laboratory: Protocol 3 (Risperidone) - 4

The purpose of this study is to evaluate clinical safety issues pertaining to risperidone, to cocaine and to its interaction, and to determine how pretreatment with risperidone modifies th...

Risperidone for Treatment of Cocaine Dependence in Outpatients - 12

The purpose of this study is to evaluate pharmacological efficacy and clinical safety of risperidone in the treatment of cocaine and amphetamine dependence.

Serotonin/Dopamine Antagonism of Cocaine Effect: 2 - 2

The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1

The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Risperidone for the Treatment of Cocaine Dependence - 7

The purpose of this study is to evaluate clinical safety and pharmacological efficacy in the treatment of cocaine dependence, to evaluate impact of treatment on craving, and to correlate e...

PubMed Articles [14648 Associated PubMed Articles listed on BioPortfolio]

Cocaine-induced multifocal leukoencephalopathy mimicking Balo's concentric sclerosis: A 2-year follow-up with serial imaging of a single patient.

Cocaine abuse may cause stroke, metabolic or multifocal inflammatory leukoencephalopathy. We described a patient with cocaine abuse who presented with Balo's type acute multifocal leukoencephalopathy....

Intercorrelation of Alcohol and Other Drug Use Disorders among a National Sample of Drivers.

This study examined the relationship between alcohol, marijuana, cocaine, and painkiller use disorders in a sample of drivers. We studied nighttime drivers aged 16 to 87 (n = 4,277) from the 2007 Na...

Examining the Association Between Psychiatric Disorders and Cocaine Binges: Results From the COSMO Study.

Although cocaine binges and mental health problems have both been identified as significant risk factors for different health hazards, little is known about the relationship between mental health and ...

Structure-Activity Relationship Studies on a Series of 3α-Bis(4-fluorophenyl)methoxytropanes and 3α-Bis(4-fluorophenyl)methylaminotropanes As Novel Atypical Dopamine Transporter (DAT) Inhibitors for the Treatment of Cocaine Use Disorders.

The development of medications to treat cocaine use disorders has thus far defied success, leaving this patient population without pharmacotherapeutic options. As the dopamine transporter (DAT) plays ...

Driving Under The Influence of Cocaine : quantitative determination of basic drugs in oral fluid obtained during roadside controls and a controlled study with cocaine users.

Using the Belgian Drugs and Driving procedure, 36% of the cocaine positive oral fluid (OF) screening results were not confirmed in plasma. This study investigates the impact of the choice of screening...

Medical and Biotech [MESH] Definitions

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.

Disorders related or resulting from abuse or mis-use of opioids.

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