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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University
ClinicalTrials.gov Identifier:
NCT00218361
First received: September 16, 2005
Last updated: June 1, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Drug: Hydromorphone
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biobehavioral Study of Opioid Drug Seeking Behavior: Study 2

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: August 2005
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.

  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 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
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: NCT00218361

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
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: NCT00218361     History of Changes
Other Study ID Numbers: NIDA-15462-2, R01DA015462, R01-15462-2, DPMC
Study First Received: September 16, 2005
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Wayne State University:
Behavioral economics
Drug self administration
Opioid

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Drug-Seeking Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014