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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

September 8, 2005
January 20, 2006
January 1997
Not Provided
  • 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)
  • Opioid agonist effects
  • Physiologic measures
Complete list of historical versions of study NCT00158236 on ClinicalTrials.gov Archive Site
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Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Opioid-Related Disorders
  • Drug: Buprenorphine
  • Drug: Buprenorphine and Naloxone
  • Drug: Hydromorphone
Not Provided
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.
 
Completed
7
March 1998
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00158236
NIDA-08045-5, R01-08045-5, DPMC
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Eric C. Strain, MD Johns Hopkins University
National Institute on Drug Abuse (NIDA)
January 2006

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