Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/13/2017 |
| Start Date: | December 2000 |
| End Date: | November 2002 |
The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone
Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse
potential. The purpose of this study is to examine the effectiveness of
buprenorphine/naloxone that is given at less than daily intervals, in order to prevent
withdrawal symptoms associated with stopping opioid abuse.
potential. The purpose of this study is to examine the effectiveness of
buprenorphine/naloxone that is given at less than daily intervals, in order to prevent
withdrawal symptoms associated with stopping opioid abuse.
Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid
dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are
attempting to stop opioid abuse; however, research suggests that individuals may be more
inclined to take medication if it is given in less than daily intervals. The purpose of this
study is to examine the opioid blockade effects of buprenorphine/naloxone that is
administered in less than daily doses to opioid dependent individuals.
This study will last 11 weeks. Participants will stay in a residential research unit for the
duration of the study. Participants will be randomly assigned to receive different doses of
daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose,
participants will undergo challenge sessions on each weekday for 1 week (Monday through
Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone.
During the challenge session week, buprenorphine/naloxone will be given only on Monday; a
placebo will be given the rest of the week. Challenge sessions will examine the blockade
effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose
of buprenorphine/naloxone.
dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are
attempting to stop opioid abuse; however, research suggests that individuals may be more
inclined to take medication if it is given in less than daily intervals. The purpose of this
study is to examine the opioid blockade effects of buprenorphine/naloxone that is
administered in less than daily doses to opioid dependent individuals.
This study will last 11 weeks. Participants will stay in a residential research unit for the
duration of the study. Participants will be randomly assigned to receive different doses of
daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose,
participants will undergo challenge sessions on each weekday for 1 week (Monday through
Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone.
During the challenge session week, buprenorphine/naloxone will be given only on Monday; a
placebo will be given the rest of the week. Challenge sessions will examine the blockade
effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose
of buprenorphine/naloxone.
Inclusion Criteria:
- Meets diagnostic criteria for opioid dependence
- Qualifies for opioid substitution treatment (e.g., methadone)
Exclusion Criteria:
- Significant psychiatric or physical disorder
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