Early Phase II Trials for Cocaine Medication Development - 1

Substance-Related Disorders Clinical Trial

Official title:

Early Phase II Trials for Cocaine Medication Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000317
• Other study ID #: #3124
• Secondary ID: R01DA009582
• Status: Completed
• Phase: Phase 2
• First received: September 20, 1999
• Last updated: June 22, 2017
• Start date: August 1996
• Est. completion date: July 1999

Study information

• Verified date: June 2017
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 1999
• Est. primary completion date: July 1999
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cocaine-Related Disorders
• Disease
• Substance-Related Disorders

Intervention

Drug:
• Risperidone
Risperidone (4mg/day)
• 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.

Locations

Country	Name	City	State
United States	NYS Psychiatric Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects	Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects	1x/week for 18 weeks
Primary	Craving	subjective cravings were recorded on the Cocaine craving scale	3x/week during 18 weeks of trial
Primary	Drug use	urine drug testing and self reported use on the Substance Use Weekly Inventory	3x/week during 18 weeks of trial
Primary	Retention	duration of individuals in the study.	18 weeks or length of study participation