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Studies of Opioid Seeking Behavior: Yohimbine and Hydrocortisone Effects (YHO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01536925
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : April 5, 2018
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University

Brief Summary:
This research deals with behaviors that are part of opioid dependence. The purpose is to study the extent to which stress and other factors, including money and amount of work effort, affect opioid choice. Specifically, the investigators will examine the effects of three issues/factors. The first is how hard participants are willing to work to obtain an opioid drug; the second is how much opioid drug would participants choose instead of money; and the third factor is how much participant's opioid drug choices are influenced after they are administered the drugs yohimbine and hydrocortisone, both of which could produce stress-like symptoms.

Condition or disease
Heroin Dependence Opioid-Related Disorders

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.

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biobehavioral Studies of Opioid Seeking Behavior: Yohimbine and Hydrocortisone Effects
Study Start Date : December 2011
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heroin dependent research volunteers

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01536925

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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Mark Greenwald, PhD Wayne State University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mark Greenwald, PhD, Professor, Wayne State University Identifier: NCT01536925    
Other Study ID Numbers: YHO-1
R01DA015462-06A1 ( U.S. NIH Grant/Contract )
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Keywords provided by Mark Greenwald, PhD, Wayne State University:
Behavioral Economics
Drug self administration
Additional relevant MeSH terms:
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Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Autonomic Agents
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents