NCT00000317

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 1996

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

2.9 years

First QC Date

September 20, 1999

Last Update Submit

June 22, 2017

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Keywords

CocaineMETHADONE PATIENTSRISPERIDONE

Outcome Measures

Primary Outcomes (4)

  • Side effects

    Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects

    1x/week for 18 weeks

  • Craving

    subjective cravings were recorded on the Cocaine craving scale

    3x/week during 18 weeks of trial

  • Drug use

    urine drug testing and self reported use on the Substance Use Weekly Inventory

    3x/week during 18 weeks of trial

  • Retention

    duration of individuals in the study.

    18 weeks or length of study participation

Study Arms (2)

PLacebo

PLACEBO COMPARATOR

Placebo plus relapse prevention counseling

Drug: PlaceboBehavioral: Relapse prevention counseling

Risperidone

EXPERIMENTAL

Risperidone (4mg/day) plus relapse prevention counseling

Drug: RisperidoneBehavioral: Relapse prevention counseling

Interventions

RisperidoneDRUG

Risperidone (4mg/day)

Also known as: Risperidal
Risperidone
PlaceboDRUG

Placebo

PLacebo
Relapse prevention counselingBEHAVIORAL

Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.

Also known as: RPT-CBT
PLaceboRisperidone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYS Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersSubstance-Related Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Edward Nunes, M.D.

    NYS Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

August 1, 1996

Primary Completion

July 1, 1999

Study Completion

July 1, 1999

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)