Opioid-Related Disorders Clinical Trial
Official title:
Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals
Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to examine the effects of buprenorphine/naloxone when given through different routes and at different doses.
Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and
effective treatment for opioid dependence. However, there is concern that buprenorphine may
be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination
tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this
study is to characterize the effects of buprenorphine/naloxone in opioid-dependent
individuals.
This study will last 10 weeks. Participants will stay in a residential research unit, and
will be maintained on oral hydromorphone (10 mg). During twice-weekly experimental sessions,
participants will be randomly assigned to receive either sublingual tablets, intramuscular
injections, or a placebo. The 15 conditions studied will include: sublingual or
intramuscular buprenorphine/naloxone (1/0.25 mg, 2/0.5 mg, 4/1 mg, 8/2 mg, and 16/4 mg),
0.25 mg of intramuscular naloxone (antagonist control), 10 mg of intramuscular hydromorphone
(agonist control), sublingual and intramuscular buprenorphine (8 mg), and placebo.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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