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

January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)

Biobehavioral Studies of Opioid Drug Seeking Behavior: Study 1

The purpose of this study is to determine whether the opportunity to take free supplemental hydromorphone (HYD) influences drug seeking behavior in heroin dependent individuals.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Drug dependence is a condition in which drug seeking holds a higher priority than behaviors controlled by other reinforcers. Learning to understand, predict, and control this maladaptive choice behavior may lead to improved prevention and treatment strategies. HYD is a drug 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 in heroin dependent individuals can be reduced by environmental factors, including supplemental opioid drug availability, drug price, and non-drug alternative reinforcers. Specifically, this study will determine whether pre-session opportunity to take "free" supplemental HYD influences HYD seeking by using a choice progressive ratio schedule as well as by varying the dose of HYD.

Participants in this observational study will undergo multiple test sessions in which they will select between acquiring drug or money. Because participants may choose money on all 12 trials of test sessions as a way to avoid receiving an injection, a placebo injection will be given when money is chosen. Prior to each test session, participants will receive a sample of the drug dose. During each test session, participants will have 12 opportunities to select either drug (administered as HYD) or money. Prior to each individual choice trial, participants will receive supplemental HYD. Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored throughout choice trials. Pupil diameter will be measured with a digital camera. Participants will complete self-report questionnaires at different times during the study. Participants will be maintained on buprenorphine throughout the study, with a fixed 3-week detoxification after study completion.

Study Type

Observational

Enrollment

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Michigan
      • Detroit, Michigan, United States, 48207
        • Wayne State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Current opiate dependence, verified by the structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
  • Positive urine test for opiates
  • Agreement to use adequate contraception for the duration of the study
  • Able to read and write English

Exclusion Criteria:

  • DSM-IV diagnosis of a psychiatric illness
  • History of or current neurological disease, including structural brain abnormalities, seizures, infection, peripheral neuropathy, and head trauma
  • History of cardiovascular disease, myocardial infarction, chest pain, edema, systolic blood pressure greater than 160 mm Hg or less than 95 mm Hg, or diastolic blood pressure greater than 95 mm Hg
  • Pulmonary disease, including obstructive pulmonary disease, cor pulmonale, tuberculosis, and asthma
  • Systemic diseases, such as endocrinopathies, liver or kidney failure, myxedema, hypothyroidism, Addison's disease, or autoimmune disease
  • Current alcohol or sedative drug dependence
  • Pregnant or breastfeeding
  • Currently receiving treatment for opioid dependence
  • Known phobia of injections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

July 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

May 1, 2006

More Information

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.

Clinical Trials on Opioid-Related Disorders

Clinical Trials on Hydromorphone

3
Subscribe