We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Early Phase II Trials for Cocaine Medication Development - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000317
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : June 26, 2017
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Substance-Related Disorders Drug: Risperidone Drug: Placebo Behavioral: Relapse prevention counseling Phase 2

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.

Study Design

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
Primary Completion Date : July 1999
Study Completion Date : July 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: PLacebo
Placebo plus relapse prevention counseling
Drug: 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
Experimental: Risperidone
Risperidone (4mg/day) plus relapse prevention counseling
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

Outcome Measures

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

  2. Craving [ Time Frame: 3x/week during 18 weeks of trial ]
    subjective cravings were recorded on the Cocaine craving scale

  3. Drug use [ Time Frame: 3x/week during 18 weeks of trial ]
    urine drug testing and self reported use on the Substance Use Weekly Inventory

  4. Retention [ Time Frame: 18 weeks or length of study participation ]
    duration of individuals in the study.

Eligibility Criteria

Information from the National Library of Medicine

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


  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

Information from the National Library of Medicine

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
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Research Foundation for Mental Hygiene, Inc.
Principal Investigator: Edward Nunes, M.D. NYS Psychiatric Institute
More Information

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:

Additional relevant MeSH terms:
Substance-Related Disorders
Cocaine-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
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
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators