Effects of Stress and Other Factors on Opiate Drug Choice. (DSS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University
ClinicalTrials.gov Identifier:
NCT00684840
First received: May 23, 2008
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

The purpose is to study the extent to which stress and other factors, including money, the amount of drug available and the amount of work effort, affect drug choice.

This study will assess whether exposure to yohimbine, a drug stressor, increases opioid craving- and -seeking behavior. We will determine whether these behavioral outcomes are associated with biobehavioral stress markers: increased saliva cortisol levels, cardiovascular response (heart rate and blood pressure), and negative mood state.


Condition
Heroin Dependence
Opioid-Related Disorders

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biobehavioral Study of Opioid Drug Seeking Behavior: Study 4

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Biospecimen Retention:   Samples With DNA

Whole Blood


Estimated Enrollment: 16
Study Start Date: March 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Physical, environmental, and pharmacological stressors have been repeatedly shown to increase self-administration of various abused substances in both preclinical and human studies. The primary aim of the proposed work is to assess the effects of yohimbine, a pharmacological agent, used to create an objectively-measured stress response, upon opioid-seeking behavior and craving.

Participants will first be an outpatient and must come to the Jefferson Avenue Research Program 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.

Next, participants will live on an inpatient research unit for at least 11 consecutive nights and possibly up to 15 consecutive nights. During this stay they will participate in a total of eight experimental sessions. Participants will take part in multiple trials in which they have the opportunity to choose drug, hydromorphone (HYD), or money. HYD is a drug that is currently used as a cough suppressant and to relieve pain. During the first two test sessions, participants will receive a sample of the drug doses that can be chosen. Before each of the final 6 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 have 12 opportunities 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.

After participants have completed the experimental procedures, they will again come to the Jefferson Ave. Research Program 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 to assess using illicit drugs.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heroin dependent research volunteers

Criteria

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

Exclusion Criteria:

  • Psychiatric illness, as determined by the DSM-IV criteria
  • History of or current neurological disease, including structural abnormalities, seizures, infection, peripheral neuropathy, and head traumas
  • History of cardiovascular disease, myocardial infarction, chest pain, or edema
  • Systolic blood pressure greater than 160mm HG or less than 95 mm HG: PR diastolic blood pressure greater than 95 mm HG.
  • Pulmonary disease, including obstructive pulmonary disease, Cor pulmonale, tuberculosis, and asthma
  • Systemic disease (e.g. endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, autoimmune disease)
  • Current alcohol or sedative drug dependence
  • Pregnant or breast feeding
  • Currently receiving treatment for opioid dependence
  • Known phobia of injections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684840

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Mark Greenwald, PhD Wayne State University
  More Information

No publications provided by Wayne State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Greenwald, PhD, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT00684840     History of Changes
Other Study ID Numbers: NIDA-15462-4, R01DA015462-04, DPMCDA
Study First Received: May 23, 2008
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Wayne State University:
Behavioral Economics
Drug self administration
Opioid

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on July 24, 2014