Cocaine DependencePhase 2/3NCT01134198
Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
A Phase 2/3 study testing Mifepristone in people with Cocaine Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This research will evaluate the impact of blocking central and peripheral glucocorticoid receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist used. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Mifepristone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 14 Feb 2018
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60.
- Male.
- Meets DSM?IV criteria for current cocaine dependence and is seeking treatment.
- Identifies life stress (work, interpersonal, financial, etc) as a trigger for cocaine use or reports uncontrollable craving to use of cocaine.
- Displays at least one cocaine-positive urine toxicology during screening.
- Uses cocaine at least 4/30 days in the past month, or reports episodic binges of large amounts of cocaine (at least $200) at least 2x/month.
- Able to give informed consent and comply with study procedures.
Who cannot join
- Meets DSM-IV criteria for major depression, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Substance Induced Mood Disorder with Hamilton Depression Scale score ³13 will be excluded.
- History of seizures in the last 2 years, or history of seizures related to the substance (cocaine, alcohol, or benzodiazepine) that the patient continues to use.
- History of allergic, dermatological, or adverse event to mifepristone
- Chronic organic mental disorder, insufficient proficiency in English that would render an individual incapable of giving informed consent.
- Significant current suicidal risks, history of significant suicidal behavior or any suicide attempt within the past year.
- Unstable physical disorders, which might make participation hazardous such as hypertension (>140/90), WBC < 3.5, new diagnosis of hepatitis (patients with chronic mildly elevated transaminase levels (£2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creat > 2; BUN > 40), or diabetes (HbA1c > 7%), and low Hb (< 12g/dL) or low Hct (<36%).
Show all 16Show fewer
- Coronary vascular disease as indicated by history, or suspected by abnormal ECG or history of cardiac symptoms. Hx of cardiac symptoms (chest pain, chest pressure, shortness of breath, syncope) during cocaine use.
- Cardiac conduction system disease as indicated by QRS duration of ³ 0.11 msec.
- Currently meets DSM-IV criteria for another substance dependence or abuse disorder other than nicotine, alcohol, or cannabis. If alcohol dependent, must not be in need of detoxification. Heavy male drinkers (who consume greater than 5 standard alcoholic drink per day per NIAAA definition) will be excluded.
- Presents with metabolic indicators of hypoadrenalism such as low serum sodium (<130 mEq/L), high serum potassium (>5.5 mEq/L), Na/K ratio < 30:1, low fasting blood sugar (<50 mg/dL), or high BUN (>20 mg/dL), or a previous history of Addison's disease or adrenal insufficiency, or the presence of low K (< 3.5 mEq/L). spot AM cortisol <5ug/dL, PM cortisol < 3 ug/dL
- Participants who cannot comply with study procedures during the initial hospitalization phase.
- Supplemental exclusion criteria for cold pressor test (CPT): history of frostbite, open cut or sore on foot to be immersed, history of Raynaud's phenomenon. During the testing, if sBP > 190 or dBP > 120, or HR > 160, the test will be interrupted. A second occurrence of these values will stop all further CPT.
- 13: Patients taking medications metabolized by cytochrome 3A4 (ex: erythromycin, protease inhibitors) or that inhibit this cytochrome; or consuming grapefruit juice.
- 14: Patients with an underlying hemorrhagic disorder and those on anti-coagulants. INR > 1.1, PT > 17 msecs, total plt <100x109/L.
- 15: Use of treatment agents that inhibit steroid biosynthesis by the adrenal cortex, such as metyrapone, ketoconazole, fluconazole, aminoglutethimide, or etomidate. Patients also requiring inhaled steroids.
- 16. Female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
This research will evaluate the impact of blocking central and peripheral glucocorticoid receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist used.
Read the detailed description
This study attempts to reduce relapse risk by blocking glucocorticoid receptors, and thus allow some of the changes in the brain caused by cocaine to redress themselves
- Conditions
- Cocaine Dependence
- Being tested
- Mifepristone, placebo
- Keywords
- Cocaine Dependence
- 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.
MifepristoneDrug
Also called RU486
Mifepristone 600mg, 3x/wk for 4 weeks
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Active comparator | Mifepristone 600mg Receives: Drug: Mifepristone |
| placebo | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Relapse by Days 10 and 28
assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed.
Measured: assessed during 8 weeks of trial, but reported for days 10 and 28 of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2016
- Study completion14 Feb 2018
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.
- Other trials for Cocaine DependenceStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfrid Raby, New York State Psychiatric Institute
- Investigators
- Wilfid N Raby, Md, PhD, Principal investigator, NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134198
- Sponsor's protocol ID
- 6013
- Other IDs
- RU486 for Cocaine Dependence
- Status last verified
- Nov 2018
- First submitted
- 26 May 2010
- Last updated
- 20 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data has been presented as an oral presentation at the annual meeting of the College on Drug Dependence in Palm Springs California on June 16th 2016. The data is presently being prepared for publication in a peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
- ClinicalTrials.gov ID
- NCT01134198
- Acronym / sponsor ID
- 6013
- Conditions
- Cocaine Dependence
- Keywords
- Cocaine Dependence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 24 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will evaluate the impact of blocking central and peripheral glucocorticoid receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist used.
Detailed description
This study attempts to reduce relapse risk by blocking glucocorticoid receptors, and thus allow some of the changes in the brain caused by cocaine to redress themselves
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Active comparator | Drug: MifepristoneMifepristone 600mg |
| placebo | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 to 60.
- Male.
- Meets DSM?IV criteria for current cocaine dependence and is seeking treatment.
- Identifies life stress (work, interpersonal, financial, etc) as a trigger for cocaine use or reports uncontrollable craving to use of cocaine.
- Displays at least one cocaine-positive urine toxicology during screening.
Key exclusion criteria (16 listed)
- Meets DSM-IV criteria for major depression, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Substance Induced Mood Disorder with Hamilton Depression Scale score ³13 will be excluded.
- History of seizures in the last 2 years, or history of seizures related to the substance (cocaine, alcohol, or benzodiazepine) that the patient continues to use.
- History of allergic, dermatological, or adverse event to mifepristone
- Chronic organic mental disorder, insufficient proficiency in English that would render an individual incapable of giving informed consent.
- Significant current suicidal risks, history of significant suicidal behavior or any suicide attempt within the past year.
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 |
|---|---|---|
| MifepristoneAlso: RU486Mifepristone 600mg, 3x/wk for 4 weeks | Drug | Mifepristone |
| placeboplacebo | Drug | placebo |
Primary outcome
Number of Participants With Relapse by Days 10 and 28
Time frame: assessed during 8 weeks of trial, but reported for days 10 and 28 of trial
assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data has been presented as an oral presentation at the annual meeting of the College on Drug Dependence in Palm Springs California on June 16th 2016. The data is presently being prepared for publication in a peer-reviewed publication.
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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.
Wilfid N Raby, Md, PhD principal investigator
NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mifepristone in people with Cocaine Dependence, 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 7 inclusion and 16 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 20 Dec 2018. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Aug 2018). 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?
Number of Participants With Relapse by Days 10 and 28 (time frame: assessed during 8 weeks of trial, but reported for days 10 and 28 of trial). 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 20 Dec 2018.