Cocaine-Related DisordersPhase 2NCT00000317
Early Phase II Trials for Cocaine Medication Development - 1
A Phase 2 study testing Risperidone and Relapse prevention counseling in people with Cocaine-Related Disorders and Substance-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine-Related Disorders, Substance-Related Disorders
- What is being tested?
- Risperidone and Relapse prevention counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1996to Jul 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Phase II Trials for Cocaine Medication Development
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
Read the 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.
- Being tested
- Risperidone, Placebo, Relapse prevention counseling
- Keywords
- Cocaine, METHADONE PATIENTS, RISPERIDONE
- Medical subject headings
- Cocaine-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperidal
Risperidone (4mg/day)
PlaceboDrug
Placebo
Relapse prevention counselingBehavioural
Also called RPT-CBT
Modified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention.
| Study group | Role | What they receive |
|---|---|---|
| PLacebo | Placebo comparator | Placebo plus relapse prevention counseling Receives: Drug: Placebo; Behavioral: Relapse prevention counseling |
| Risperidone | Experimental | Risperidone (4mg/day) plus relapse prevention counseling Receives: Drug: Risperidone; Behavioral: Relapse prevention counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side effects
Using the Modified Systemic Assessment for Treatment Emergent Effects the psychiatrist assessed side effects
Measured: 1x/week for 18 weeks
Craving
subjective cravings were recorded on the Cocaine craving scale
Measured: 3x/week during 18 weeks of trial
Drug use
urine drug testing and self reported use on the Substance Use Weekly Inventory
Measured: 3x/week during 18 weeks of trial
Retention
duration of individuals in the study.
Measured: 18 weeks or length of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startAug 1996
- Primary completionJul 1999
- Study completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.
- Responsible party
- Sponsor
- Investigators
- Edward Nunes, M.D., Principal investigator, NYS Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000317
- Sponsor's protocol ID
- #3124
- Other IDs
- R01DA009582
- Status last verified
- Jun 2017
- First submitted
- 20 Sep 1999
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase II Trials for Cocaine Medication Development
- ClinicalTrials.gov ID
- NCT00000317
- Acronym / sponsor ID
- #3124
- Keywords
- Cocaine, METHADONE PATIENTS, RISPERIDONE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Research Foundation for Mental Hygiene, Inc.
- Study start
- Aug 1996 (actual)
- Primary completion
- Jul 1999 (actual)
- Study completion
- Jul 1999 (actual)
- First posted
- 21 Sep 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLacebo | Placebo comparator | Drug: Placebo, Behavioral: Relapse prevention counselingPlacebo plus relapse prevention counseling |
| Risperidone | Experimental | Drug: Risperidone, Behavioral: Relapse prevention counselingRisperidone (4mg/day) plus relapse prevention counseling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneAlso: RisperidalRisperidone (4mg/day) | Drug | Risperidone |
| PlaceboPlacebo | Drug | PLacebo |
| Relapse prevention counselingAlso: RPT-CBTModified manual guided relapse prevention counseling. Weekly 20 minute sessions consisting of cognitive behavioral skills. Both arms will receive this intervention. | Behavioural | PLacebo, Risperidone |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Nunes, M.D. principal investigator
NYS Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Risperidone and Relapse prevention counseling in people with Cocaine-Related Disorders and Substance-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effects (time frame: 1x/week for 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.