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Effects of Environmental Factors on Opiate Drug Choice in Opioid Dependent Individuals. (DSC)
This study has been completed.
First Received: January 31, 2008   Last Updated: April 13, 2009   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
Wayne State University
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00608504
  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

MedlinePlus related topics: Heroin
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Biobehavioral Study of Opioid Drug Seeking Behavior: Study 3

Further study details as provided by National Institute on Drug Abuse (NIDA):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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
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

Responsible Party: Wayne State University ( Mark Greenwald Ph.D. )
Study ID Numbers: NIDA-15462-3, R01-DA015462-3, DPMCDA
Study First Received: January 31, 2008
Last Updated: April 13, 2009
ClinicalTrials.gov Identifier: NCT00608504     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Behavioral Economics
Drug self administration
Opioid

Study placed in the following topic categories:
Mental Disorders
Heroin Dependence
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin
Peripheral Nervous System Agents
Analgesics
Opioid-Related Disorders
Analgesics, Opioid

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

ClinicalTrials.gov processed this record on May 07, 2009