Cocaine DependencePhase 2NCT00385801
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
A Phase 2 study testing Risperidone in people with Cocaine Dependence, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Risperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- current cocaine dependence who use cocaine at least every 2 weeks
- Non-treatment seekers who intend to continue using cocaine
- Male 18-60 years of age
- Potential participants must be literate in the English language, and be able to understand and complete rating scales and questionnaires accurately
- Able to provide informed consent
- Potential participants must be able to identify at least one "locator" person to assist in tracking the participant for follow-up assessments
Who cannot join
- Other current substance dependence requiring immediate detoxification
- Diagnosis of schizophrenia, bipolar disorder, current major depressive disorder
- Currently suicidal or at high risk for suicide in the judgment of the investigator
- Carrying a medical device incompatible with MRI (e.g., metal implants such as surgical clips or pacemakers and extensive dental work such as bridges) or suffering from significant claustrophobia that would make MRI unfeasible.
- Size incompatible with MRI procedures
- Serious medical illness including HIV-1 infection
Show all 17Show fewer
- Hepatitis C + titer with liver enzymes more than 2x normal or a Mini-Mental Status Exam Score of <25/30
- Insulin dependent diabetes mellitus (IDDM) or non- insulin dependent diabetes mellitus (NIDDM) and abnormal Hemoglobin A1C
- Severe hepatic or renal impairment
- History of seizure disorder, delirium, dementia, or mental disorders due to general medical conditions
- History of head trauma or stroke with lasting neurological sequelae
- Tardive dyskinesia, extrapyramidal movement disorder, Parkinson's Disease or history of Neuroleptic Malignant Syndrome
- Clinical or laboratory evidence of uncontrolled hypothyroidism/hyperthyroidism
- Orthostatic hypotension, defined as a decrease of at > 10 mm Hg in systolic blood pressure and/or an increase in heart rate of > 20 beats per minute, measured one minute following transition from a supine to a standing position.
- History of allergy or hypersensitivity to Risperidone
- Treatment with: Neuroleptics, Antidepressants, Antiarrhythmics, Carbamazepine, Phenytoin, Valproate, Rifampin, Phenobarbital, Levodopa and other dopamine agonists, Fluoxetine, Interferon, Propylthiouracil, Methimazole, Opiates.
- Treatment within 30 days prior to screening with an investigational drug or medication with the potential to influence cocaine use outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
MGH Addiction Research Program
Boston, Massachusetts, 02114
About this study
Official title: A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence
The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.
- Conditions
- Cocaine Dependence
- Being tested
- Risperidone, Placebo
- Keywords
- cocaine, dependence, risperidal, MRI
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Identical placebo tablets and injections Receives: Drug: Placebo |
| risperidone consta | Active comparator | Risperidone 1-2 mg tablets and Risperidone 25 mg injections Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues
Measure of Dispersion/Precision not calculated, and raw data are no longer available
Measured: 12 weeks
Cocaine Use by Quantitative Urine Samples
After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below
Measured: 12 weeks
Secondary outcomes (2)
Cocaine Craving
The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week)
Measured: 12 weeks
Amygdala Volume by MRI
Measure of Dispersion/Precision not calculated, and raw data are no longer available
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP
- Responsible party
- Principal investigator, A. Eden Evins, Massachusetts General Hospital
- Investigators
- Eden A Evins, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385801
- Sponsor's protocol ID
- RIS-EMR-4021
- Status last verified
- Mar 2017
- First submitted
- 6 Oct 2006
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Loebl T, Angarita GA, Pachas GN, Huang KL, Lee SH, Nino J, Logvinenko T, Culhane MA, Evins AE. A randomized, double-blind, placebo-controlled trial of long-acting risperidone in cocaine-dependent men. J Clin Psychiatry. 2008 Mar;69(3):480-6. doi: 10.4088/jcp.v69n0321.
PubMed 18294021
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of the Effects of Risperdal Consta on Brain Reward Circuitry, Craving and Cocaine Use in Active Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00385801
- Acronym / sponsor ID
- RIS-EMR-4021
- Conditions
- Cocaine Dependence
- Keywords
- cocaine, dependence, risperidal, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Janssen, LP
- Study start
- Sep 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Oct 2006 (estimated)
- Results
- Posted 28 Apr 2017
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 examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIdentical placebo tablets and injections |
| risperidone consta | Active comparator | Drug: RisperidoneRisperidone 1-2 mg tablets and Risperidone 25 mg injections |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- current cocaine dependence who use cocaine at least every 2 weeks
- Non-treatment seekers who intend to continue using cocaine
- Male 18-60 years of age
- Potential participants must be literate in the English language, and be able to understand and complete rating scales and questionnaires accurately
- Able to provide informed consent
Key exclusion criteria (17 listed)
- Other current substance dependence requiring immediate detoxification
- Diagnosis of schizophrenia, bipolar disorder, current major depressive disorder
- Currently suicidal or at high risk for suicide in the judgment of the investigator
- Carrying a medical device incompatible with MRI (e.g., metal implants such as surgical clips or pacemakers and extensive dental work such as bridges) or suffering from significant claustrophobia that would make MRI unfeasible.
- Size incompatible with MRI procedures
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 |
|---|---|---|
| Risperidone | Drug | risperidone consta |
| Placebo | Drug | Placebo |
Primary outcome
Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues
Time frame: 12 weeks
Measure of Dispersion/Precision not calculated, and raw data are no longer available
Cocaine Use by Quantitative Urine Samples
Time frame: 12 weeks
After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below
2 secondary outcomes
Cocaine Craving
Time frame: 12 weeks
Amygdala Volume by MRI
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 18294021Loebl T, Angarita GA, Pachas GN, Huang KL, Lee SH, Nino J, Logvinenko T, Culhane MA, Evins AE. A randomized, double-blind, placebo-controlled trial of long-acting risperidone in cocaine-dependent men. J Clin Psychiatry. 2008 Mar;69(3):480-6. doi: 10.4088/jcp.v69n0321.
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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.
Eden A Evins, MD MPH principal investigator
Massachusetts General Hospital
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 in people with Cocaine Dependence, run by Massachusetts General Hospital 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 6 inclusion and 17 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 28 Apr 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?
Yes. Results are posted in the registry (first posted 28 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385801, which also lists 1 linked publication.
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 28 Apr 2017.