Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Opioid-Related Disorders |
Drug: Buprenorphine Drug: Buprenorphine and Naloxone Drug: Hydromorphone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers |
- 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)
| Estimated Enrollment: | 7 |
| Study Start Date: | January 1997 |
| Estimated Study Completion Date: | March 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Maryland | |
| Johns Hopkins University (BPRU) Bayview Campus | |
| Baltimore, Maryland, United States, 21224 6823 | |
| Principal Investigator: | Eric C. Strain, MD | Johns Hopkins University |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00158236 History of Changes |
| Other Study ID Numbers: | NIDA-08045-5, R01-08045-5, DPMC |
| Study First Received: | September 8, 2005 |
| Last Updated: | January 20, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Opiate Addiction Opiate Dependence |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Hydromorphone Analgesics, Opioid Naloxone Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013