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

May 23, 2008
June 1, 2012
March 2008
December 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00684840 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Stress and Other Factors on Opiate Drug Choice.
Biobehavioral Study of Opioid Drug Seeking Behavior: Study 4

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole Blood

Non-Probability Sample

Heroin dependent research volunteers

  • Heroin Dependence
  • Opioid-Related Disorders
Not Provided
Not Provided
Greenwald MK, Lundahl LH, Steinmiller CL. Yohimbine increases opioid-seeking behavior in heroin-dependent, buprenorphine-maintained individuals. Psychopharmacology (Berl). 2013 Feb;225(4):811-24. doi: 10.1007/s00213-012-2868-9. Epub 2012 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00684840
NIDA-15462-4, R01DA015462-04, DPMCDA
Yes
Mark Greenwald, PhD, Wayne State University
Wayne State University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Mark Greenwald, PhD Wayne State University
Wayne State University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP