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Effects of Post-Session Supplemental Hydromorphone on Drug Seeking Behavior in Opioid Dependent Individuals

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ClinicalTrials.gov Identifier: NCT00218361
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 5, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University

Study Description
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Brief Summary:
The purpose of this study is to determine whether knowledge of post-session hydromorphone (HYD) availability reduces drug seeking behavior in heroin dependent individuals.

Condition or disease Intervention/treatment
Heroin Dependence Opioid-Related Disorders Drug: Hydromorphone

Detailed Description:

Drug dependence is often characterized by severe drug seeking behavior. Learning to understand, predict, and control this maladaptive choice behavior may lead to improved prevention and treatment strategies. HYD is a drug that is currently used as a cough suppressant and to relieve pain. The purpose of this study is to determine the extent to which opioid drug seeking behavior by heroin dependent individuals can be reduced by environmental factors, including supplemental opioid drug availability, drug price, and alternative non-drug reinforcers. Specifically, this study will determine whether knowledge of post-session HYD availability influences drug seeking behavior in heroin dependent individuals, who are maintained on buprenorphine during their participation.

Participants in this observational study will take part in multiple trials in which they have the opportunity to choose either 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. Supplemental HYD will be made available following some choice sessions. 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 Design
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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biobehavioral Study of Opioid Drug Seeking Behavior: Study 2
Study Start Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
Whole Blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heroin dependent research volunteers
Criteria

Inclusion Criteria:

  • Opioid dependent, as determined by the 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 160 mm 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 breastfeeding
  • Currently receiving treatment for opioid dependence
  • Known phobia of injections
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218361


Locations
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United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
Sponsors and Collaborators
Wayne State University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Mark Greenwald, PhD Wayne State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mark Greenwald, PhD, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT00218361    
Other Study ID Numbers: NIDA-15462-2
R01DA015462 ( U.S. NIH Grant/Contract )
R01-15462-2
DPMC
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012
Keywords provided by Mark Greenwald, PhD, Wayne State University:
Behavioral economics
Drug self administration
Opioid
Additional relevant MeSH terms:
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Opioid-Related Disorders
Heroin Dependence
Drug-Seeking Behavior
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hydromorphone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents