Effects of Environmental Factors on Opiate Drug Choice in Opioid Dependent Individuals. (DSC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University
ClinicalTrials.gov Identifier:
NCT00608504
First received: January 31, 2008
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

The purpose is to study how certain factors, including money, the amount of drug available and the amount of work effort, affect opiate drug choice.


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 3

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: July 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:

A drug dependent person chooses to take drug more often (and suffer its long-term bad consequences) than choosing to engage in healthy activities (which have better long-term consequences). The present research will be conducted in a controlled laboratory setting with heroin abusers who are not seeking treatment to understand what factors guide their choices.

This research focuses on environmental (i.e. non-medication) factors that affect choosing a drug versus money. Findings from this research are likely to be important in developing a theoretical and practical basis for behavioral interventions as part of drug abuse treatment. HYD is a drug that is currently used as a cough suppressant and to relieve pain.

Participants in this observational study will take part in multiple trials in which they have the opportunity to choose HYD or money. On the first two experimental days, prior to choice sessions, participants will receive a sample of the drug doses that can be chosen. During test sessions, participants will have 12 opportunities to choose either drug or money. Participants will use 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.

Participants will be maintained on buprenorphine throughout the study, with a minimum 2-week lead before the experiment, and a fixed 3-week detoxification after study completion.

  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: NCT00608504

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: NCT00608504     History of Changes
Other Study ID Numbers: NIDA-15462-3, R01DA015462-03, DPMCDA
Study First Received: January 31, 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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 21, 2014