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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00134914 |
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.
Condition | Intervention |
Opioid-Related Disorders |
Drug: Buprenorphine |
ChemIDplus related topics: | Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals |
Enrollment: | 10 |
Study Start Date: | August 1996 |
Study Completion Date: | May 1998 |
Primary Completion Date: | April 1998 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |||||
Johns Hopkins University (BPRU) Bayview Campus | |||||
Baltimore, Maryland, United States, 21224 6823 |
Principal Investigator: | Eric C. Strain, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University School of Medicine ( Eric C. Strain/Principal Investigator ) |
Study ID Numbers: | NIDA-08045-4, R01-08045-4, DPMC |
First Received: | August 23, 2005 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00134914 |
Health Authority: | United States: Food and Drug Administration |
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