Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/13/2017 |
| Start Date: | January 1997 |
| End Date: | March 1998 |
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.
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
