Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users

This study has been completed.

Sponsor:

Information provided by:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT00158236

First received: September 8, 2005

Last updated: January 20, 2006

Last verified: January 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

January 20, 2006

Start Date ^ICMJE

January 1997

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Opioid agonist effects (measured by Visual Analog Scale and Adjective Rating Scale during the medication challenge sessions)
Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the medication challenge sessions)

Original Primary Outcome Measures ^ICMJE

Opioid agonist effects
Physiologic measures

Change History

Complete list of historical versions of study NCT00158236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users

Official Title ^ICMJE

Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

Brief Summary

Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihood of buprenorphine addiction. This study will evaluate the potential for abuse of buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.

Detailed Description

Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail. Individuals with severe opioid withdrawal may experience shaking, muscle and bone pain, nausea, depression, anxiety, and drug craving. Buprenorphine, a medication that is used to treat opioid addiction, works by lessening the withdrawal symptoms. However, past research has shown that individuals who use buprenorphine are at risk for abusing the drug. Naloxone, another medication, is currently used to treat substance addiction. It is also used in combination with buprenorphine to reduce the risk of buprenorphine abuse in individuals who are physically dependent upon opioids. The purpose of this study is to compare the abuse potential of buprenorphine versus a buprenorphine and naloxone combination in non-dependent opioid users.

This 7-week study will enroll non-dependent opioid users. Participants will take part in two medication challenge sessions per week. At each challenge session, participants will be randomly assigned to receive varying doses of either buprenorphine; a buprenorphine and naloxone combination; hydromorphone, which is a medication used to treat moderate to severe pain; or placebo. Buprenorphine and naloxone will be administered as tablets that are dissolved under the tongue. Hydromorphone will be injected. During the challenge sessions, participants will complete performance tasks to measure psychomotor and cognitive functioning. Questionnaires and self-reports will be completed to assess medication effects. Heart rate and blood pressure will be monitored throughout all sessions, and a specialized camera will be used to assess pupillary response of the eyes.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Buprenorphine
Drug: Buprenorphine and Naloxone
Drug: Hydromorphone

Study Arm (s)

Not Provided

Publications *

Strain EC, Stoller K, Walsh SL, Bigelow GE. Effects of buprenorphine versus buprenorphine/naloxone tablets in non-dependent opioid abusers. Psychopharmacology (Berl). 2000 Mar;148(4):374-83.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 1998

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Current opioid abuse
Not physically dependent on opioids

Exclusion Criteria:

Significant medical or psychiatric illness (e.g., insulin-dependent diabetes or schizophrenia)
Seeking substance abuse treatment (will be assisted with referrals to community-based treatment programs)
Pregnant

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00158236

Other Study ID Numbers ^ICMJE

NIDA-08045-5, R01-08045-5, DPMC

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eric C. Strain, MD

Johns Hopkins University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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