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

Opioid-Related Disorders Clinical Trial

Official title:

Biobehavioral Study of Opioid Drug Seeking Behavior: Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218361
• Other study ID #: NIDA-15462-2
• Secondary ID: R01DA015462R01-1
• Status: Completed
• Phase: Phase 1
• First received: September 16, 2005
• Last updated: June 1, 2012
• Start date: August 2005

Study information

• Verified date: June 2012
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Hydromorphone

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States,