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

Opioid-Related Disorders Clinical Trial

Official title:

Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158236
• Other study ID #: NIDA-08045-5
• Secondary ID: R01-08045-5DPMC
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: January 11, 2017
• Start date: January 1997
• Est. completion date: March 1998

Study information

• Verified date: January 2006
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: March 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine

• Buprenorphine and Naloxone

• Hydromorphone

Locations

Country	Name	City	State
United States	Johns Hopkins University (BPRU) Bayview Campus	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid agonist effects (measured by Visual Analog Scale and Adjective Rating Scale during the medication challenge sessions)
Primary	Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the medication challenge sessions)