Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
Information source: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders
Intervention: Buprenorphine (Drug); Buprenorphine and Naloxone (Drug); Hydromorphone (Drug)
Sponsored by: National Institute on Drug Abuse (NIDA)
Official(s) and/or principal investigator(s):
Eric C. Strain, MD, Principal Investigator, Affiliation: Johns Hopkins University
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.
Official title: Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 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.
Minimum age: 18 Years.
Maximum age: 55 Years.
- Current opioid abuse
- Not physically dependent on opioids
- Significant medical or psychiatric illness (e. g., insulin-dependent diabetes or
- Seeking substance abuse treatment (will be assisted with referrals to community-based
Locations and Contacts
Johns Hopkins University (BPRU) Bayview Campus, Baltimore, Maryland 21224 6823, United States
Starting date: January 1997
Last updated: January 20, 2006