- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01536925
Studies of Opioid Seeking Behavior: Yohimbine and Hydrocortisone Effects (YHO)
Biobehavioral Studies of Opioid Seeking Behavior: Yohimbine and Hydrocortisone Effects
Study Overview
Status
Conditions
Detailed Description
Phase 1: Participants will first be an outpatient and must come to the Tolan Park Medical Building daily to receive buprenorphine doses. This phase will last at least 10 days or longer. Three times per week during the first two weeks (i.e., on 6 different days), participants will be asked to provide urine samples and to complete questionnaires that ask about opiate withdrawal symptoms.
Phase 2: Participants will then live on an inpatient research unit (located in Detroit Michigan) for at least 16 consecutive nights and possibly up to 18 consecutive nights. Participants will continue on the same dose of buprenorphine as in phase 1.
During this stay they will participate in a total of 11 experimental sessions. Participants will take part in multiple trials in which they have the opportunity to choose drug, hydromorphone, or money. Hydromorphone is a heroin-like opioid. During the first two test sessions, participants will receive a sample of the drug doses that can be chosen. Before each of the final 9 test sessions begin, participants will be given a capsule containing either different doses of the drug yohimbine or a placebo (blank). Yohimbine is a drug that has been shown to produce a "stress"-like response in humans. Then participants will be given a capsule that contains either different doses of the drug hydrocortisone or a placebo (blank). Hydrocortisone is also a drug that can produce a "stress"-like response in humans. Then participants will have the opportunity to choose either drug or money by using a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. Self-report questionnaires will be completed at different times during the study.
Phase 3: After participants have completed the experimental procedures, they will again come to the Tolan Park Medical Building daily to receive buprenorphine doses. The dose of buprenorphine will be gradually decreased so that they will eventually be free from medication. This will take three weeks. We will administer questionnaires and collect urine samples three times each week.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Opioid dependent, as determined by structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
- Positive urine test for opiates
- Willing to use an adequate form of contraception for the duration of the study.
- Reads and writes English
- Participants must be in generally good health to be eligible. All candidates will receive a routine medical exam (history and physical) with standard laboratory tests (including blood and urine samples, EKG, mandatory TB testing, and voluntary HIV testing).
Exclusion Criteria:
- No candidate who has a current DSM-IV Axis I disorder other than Drug Dependence or a history of serious psychiatric problems (e.g. psychosis, bipolar or major depression) will be allowed to participate.
- Candidates meeting criteria for opioid or nicotine dependence will not be excluded, but those with other Substance Dependence disorders will be excluded. Those with Abuse of Alcohol, Cannabis, Cocaine, or Benzodiazepines will not be excluded, but participants must provide an alcohol free breath specimen, and a benzodiazepine free urine sample.
- No candidate with medical (neurological, cardiovascular, pulmonary or systemic) disorders will be allowed to participate. This will be determined with history and physical exam, standard laboratory testing (blood and urine), EKG, and TB tests (to avoid transmitting this communicable disease on the residential unit or in the laboratory).
- Candidates with evidence of cognitive impairment (based on reading ability and comprehension, will be excluded.
- Female candidates who are pregnant (urine pregnancy test), lactating, or not using adequate birth control methods (self-report) will be excluded.
- Candidates with injection phobia, or seeking treatment for opioid dependence will be excluded.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YHO-1
- R01DA015462-06A1 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opioid-Related Disorders
-
Bicycle HealthEnrolling by invitationOpioid Use Disorder | Opioid Dependence | Opioid Use | Opioid Abuse | Opioid MisuseUnited States
-
Baylor College of MedicineChandrakantanWithdrawnOpioid Dependence | Opioid Use | Opioid Abuse, Unspecified
-
MindLight, LLCHarvard Medical School (HMS and HSDM); National Institute on Drug Abuse (NIDA) and other collaboratorsCompletedOpioid Dependence | Opioid Abuse | Opioid-use DisorderUnited States
-
University of ArkansasNational Institute on Drug Abuse (NIDA)CompletedOpioid Dependence | Opioid Withdrawal | Opioid DetoxificationUnited States
-
The University of Texas Health Science Center at...TerminatedOpioid Dependence | Opioid Abuse, UnspecifiedUnited States
-
New York State Psychiatric InstituteColumbia University; Weill Medical College of Cornell University; National Institute... and other collaboratorsActive, not recruitingOpioid Use | Opioid Court Model | Medication to Treat Opioid Use DisorderUnited States
-
Vanderbilt University Medical CenterCompletedOpioid Use | Opioid-use DisorderUnited States
-
University of PennsylvaniaCompletedSurgery | Opioid Use | Opioid Misuse | Prescription Opioid MisuseUnited States
-
Indiana UniversityCompletedOpioid Use | Opioid-use DisorderUnited States
-
University of MinnesotaRecruitingOpioid Dependence | Opioid Abuse | Opioid-use DisorderUnited States