Early Phase II Trials for Cocaine Medication Development - 1
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| ClinicalTrials.gov Identifier: NCT00000317 |
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Recruitment Status :
Completed
First Posted : September 21, 1999
Last Update Posted : June 26, 2017
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cocaine-Related Disorders Substance-Related Disorders | Drug: Risperidone Drug: Placebo Behavioral: Relapse prevention counseling | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 31 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Early Phase II Trials for Cocaine Medication Development |
| Actual Study Start Date : | August 1996 |
| Actual Primary Completion Date : | July 1999 |
| Actual Study Completion Date : | July 1999 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: PLacebo
Placebo plus relapse prevention counseling
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Drug: Placebo
Placebo Behavioral: Relapse prevention counseling Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.
Other Name: RPT-CBT |
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Experimental: Risperidone
Risperidone (4mg/day) plus relapse prevention counseling
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Drug: Risperidone
Risperidone (4mg/day)
Other Name: Risperidal Behavioral: Relapse prevention counseling Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.
Other Name: RPT-CBT |
- Side effects [ Time Frame: 1x/week for 18 weeks ]Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects
- Craving [ Time Frame: 3x/week during 18 weeks of trial ]subjective cravings were recorded on the Cocaine craving scale
- Drug use [ Time Frame: 3x/week during 18 weeks of trial ]urine drug testing and self reported use on the Substance Use Weekly Inventory
- Retention [ Time Frame: 18 weeks or length of study participation ]duration of individuals in the study.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion:
- good standing at methadone maintenance program
- DSM-IV criteria for cocaine dependence or abuse
- used cocaine at least 4 times in last month
- able to give informed consent
Exclusion criteria
- currently meets DSM-IV criteria for Major depression or dysthymia
- meets DSM-IV criteria for attention deficit hyperactivity disorder, bipolar disorder, schizophrenia or any psychotic disorder
- history of seizures
- history of allergic reaction to risperidone
- chronic organic mental disorder
- significant current suicidal risk
- pregnancy, lactation or failure to use adequate birth control (for females)
- unstable physical disorders that may make participation hazardous
- coronary vascular disease
- cardiac conduction system disease as indicated by QRS duration >/= 0.11
- current use of other prescribed psychotropic medications
- history of failure to respond to a previous adequate trial of risperidone
- history of neuroleptic malignant syndrome, tardive dyskinesia, or severe extrapyramidal reactions to neuroleptic medications
- current DSM-IV criteria for another substance dependence other than nicotine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000317
| United States, New York | |
| NYS Psychiatric Institute | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Edward Nunes, M.D. | NYS Psychiatric Institute |
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT00000317 History of Changes |
| Obsolete Identifiers: | NCT00000272 |
| Other Study ID Numbers: |
#3124 R01DA009582 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 21, 1999 Key Record Dates |
| Last Update Posted: | June 26, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by New York State Psychiatric Institute:
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Cocaine METHADONE PATIENTS RISPERIDONE |
Additional relevant MeSH terms:
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Disease Substance-Related Disorders Cocaine-Related Disorders Pathologic Processes Chemically-Induced Disorders Mental Disorders Risperidone Cocaine Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Anesthetics, Local Anesthetics Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators |