- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00608504
Effects of Environmental Factors on Opiate Drug Choice in Opioid Dependent Individuals. (DSC)
Biobehavioral Study of Opioid Drug Seeking Behavior: Study 3
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Wayne State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Woodcock EA, Lundahl LH, Burmeister M, Greenwald MK. Functional mu opioid receptor polymorphism (OPRM1 A(118) G) associated with heroin use outcomes in Caucasian males: A pilot study. Am J Addict. 2015 Jun;24(4):329-35. doi: 10.1111/ajad.12187. Epub 2015 Apr 24.
- Stoltman JJ, Woodcock EA, Lister JJ, Greenwald MK, Lundahl LH. Exploration of the telescoping effect among not-in-treatment, intensive heroin-using research volunteers. Drug Alcohol Depend. 2015 Mar 1;148:217-20. doi: 10.1016/j.drugalcdep.2015.01.010. Epub 2015 Jan 19.
- Greenwald MK, Steinmiller CL, Sliwerska E, Lundahl L, Burmeister M. BDNF Val(66)Met genotype is associated with drug-seeking phenotypes in heroin-dependent individuals: a pilot study. Addict Biol. 2013 Sep;18(5):836-45. doi: 10.1111/j.1369-1600.2011.00431.x. Epub 2012 Feb 16.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-15462-3
- DPMCDA (Other Identifier: NIDA)
- R01DA015462-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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