Assessing Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/13/2017 |
| Start Date: | December 2000 |
| End Date: | December 2017 |
Abuse Potential of Parenteral Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Buprenorphine, a treatment for opioid dependence, can be mixed with another drug, naloxone,
to limit abuse potential. Parenteral administration (intravenous or intramuscular injection)
of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals.
However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This
study will investigate whether naloxone decreases the opioid agonist effect from injected
buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in
non-dependent opioid abusers.
to limit abuse potential. Parenteral administration (intravenous or intramuscular injection)
of buprenorphine/naloxone causes withdrawal symptoms in opioid dependent individuals.
However, naloxone does not cause withdrawal symptoms in non-dependent opioid abusers. This
study will investigate whether naloxone decreases the opioid agonist effect from injected
buprenorphine, hence decreasing the abuse potential of buprenorphine/naloxone, in
non-dependent opioid abusers.
Naloxone has been combined with buprenorphine to decrease the parenteral abuse potential of
buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated
withdrawal. While naloxone will not precipitate withdrawal in individuals who are not
physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's
agonist effects, especially if administered parenterally. The purpose of this study is to
assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and
buprenorphine/naloxone in non-dependent opioid abusers.
Participants will stay on a research ward and will undergo challenge sessions twice per
week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an
opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM
buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM
buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological
status will be recorded continuously and tasks assessing psychomotor, subjective, and
objective status will be performed repeatedly.
buprenorphine in opioid dependent individuals through the mechanism of naloxone-precipitated
withdrawal. While naloxone will not precipitate withdrawal in individuals who are not
physically dependent on opioids, it is possible naloxone might attenuate buprenorphine's
agonist effects, especially if administered parenterally. The purpose of this study is to
assess the effect of sublingual (SL) and intramuscular (IM) buprenorphine and
buprenorphine/naloxone in non-dependent opioid abusers.
Participants will stay on a research ward and will undergo challenge sessions twice per
week. The following conditions will be tested: placebo; IM hydromorphone (2 and 4 mg; an
opioid agonist positive control condition); SL buprenorphine (4, 8, and 16 mg); IM
buprenorphine (4, 8, and 16 mg); SL buprenorphine/naloxone(4/1, 8/2, and 16/4 mg); and IM
buprenorphine/naloxone (4/1, 8/2, and 16/4 mg). During challenge sessions, physiological
status will be recorded continuously and tasks assessing psychomotor, subjective, and
objective status will be performed repeatedly.
Inclusion Criteria:
- Non-dependent opioid abuser
- Actively abusing opioids by injection
Exclusion Criteria:
- Opioid dependence
- Signs or symptoms of opioid withdrawal, once admitted to residential unit
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