Early Phase II Trials for Cocaine Medication Development - 1

This study has been completed.
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00000317
First received: September 20, 1999
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Cocaine-Related Disorders
Substance-Related Disorders
Drug: Risperidone
Drug: Placebo
Behavioral: Relapse prevention counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Early Phase II Trials for Cocaine Medication Development

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Side effects [ Time Frame: 1x/week for 18 weeks ] [ Designated as safety issue: Yes ]
    Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects

  • Craving [ Time Frame: 3x/week during 18 weeks of trial ] [ Designated as safety issue: No ]
    subjective cravings were recorded on the Cocaine craving scale

  • Drug use [ Time Frame: 3x/week during 18 weeks of trial ] [ Designated as safety issue: No ]
    urine drug testing and self reported use on the Substance Use Weekly Inventory

  • Retention [ Time Frame: 18 weeks or length of study participation ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 1996
Study Completion Date: July 1999
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PLacebo
Placebo plus relapse prevention
Drug: Placebo
Placebo
Behavioral: Relapse prevention counseling
Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills.
Other Name: RPT-CBT
Experimental: Risperidone
Risperidone (4mg/day)plus relapse prevention
Drug: Risperidone
Risperidone (4mg/day)
Behavioral: Relapse prevention counseling
Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills.
Other Name: RPT-CBT

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. good standing at methadone maintenance program
  2. DSM-IV criteria for cocaine dependence or abuse
  3. used cocaine at least 4 times in last month
  4. able to give informed consent

Exclusion criteria

  1. currently meets DSM-IV criteria for Major depression or dysthymia
  2. meets DSM-IV criteria for attention deficit hyperactivity disorder, bipolar disorder, schizophrenia or any psychotic disorder
  3. history of seizures
  4. history of allergic reaction to risperidone
  5. chronic organic mental disorder
  6. significant current suicidal risk
  7. pregnancy, lactation or failure to use adequate birth control (for females)
  8. unstable physical disorders that may make participation hazardous
  9. coronary vascular disease
  10. cardiac conduction system disease as indicated by QRS duration >/= 0.11
  11. current use of other prescribed psychotropic medications
  12. history of failure to respond to a previous adequate trial of risperidone
  13. history of neuroleptic malignant syndrome, tardive dyskinesia, or severe extrapyramidal reactions to neuroleptic medications
  14. current DSM-IV criteria for another substance dependence other than nicotine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000317

Locations
United States, New York
Research Foundation for Mental Hygiene
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Edward Nunes, M.D. Research Foundation for Mental Hygiene, Inc.
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00000317     History of Changes
Other Study ID Numbers: #3124, R01DA009582, R01-09582-1
Study First Received: September 20, 1999
Last Updated: October 24, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 23, 2014