Buprenorphine is a treatment for opioid dependence. Naloxone is given in conjunction with buprenorphine to limit the abuse potential of buprenorphine. This study examines the effects of the drug combination when administered through different routes and at different doses.

Condition	Intervention
Opioid-Related Disorders	Drug: Buprenorphine

Further Study Details: 

Primary Outcomes: Opioid agonist rating; Opiate withdrawal; Physiologic measures
Expected Total Enrollment:  10

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that it may be abused. A sublingual (SL) buprenorphine/naloxone (B/N) combination tablet may reduce this risk by capitalizing on the differentially poor SL bioavailability of the opioid antagonist naloxone. While discouraging parenteral injection due to the possibility of precipitated withdrawal in opioid-dependent individuals, naloxone should have little or no biodelivery or effect if the B/N is taken sublingually. This study characterizes the effects of B/N combinations in opioid-dependent volunteers. During a 10 week residential research unit admission, subjects were maintained on oral hydromorphone (10 mg q.i.d.). In twice-weekly experimental sessions, subjects received SL tablets, intramuscular (IM) injections, or control (double-blind, double-dummy). The 15 conditions included: B/N SL or IM (1/0.25, 2/0.5, 4/1, 8/2, 16/4 mg), 0.25 mg naloxone IM (antagonist control), 10 mg hydromorphone IM (agonist control), 8 mg buprenorphine monotherapy SL tablet or IM (buprenorphine control), and placebo. SL B/N produced, at most, mild effects at all dose conditions. IM B/N produced robust dose-related antagonist effects within minutes of administration, and some modest delayed agonist effects. Similar effects were observed for 8 mg B/N vs. 8 mg buprenorphine SL tablets. The 8 mg B/N combination, but not 8 mg buprenorphine alone, produced intense antagonist effects when given IM. In summary, the combination of buprenorphine and naloxone produces antagonist effects when taken IM, but not SL.

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Male and female documented opiate addicts seeking and eligible for methadone maintenance or detoxification treatment.

Inclusion Criteria:

currently opioid dependent, demonstrated good health in a pre-participation medical examination

Exclusion Criteria:

significant medical or psychiatric illness other than drug dependence

Please refer to this study by ClinicalTrials.gov identifier  NCT00134914

Eric C Strain, M.D.      (410)550-1191    ecsgss@aol.com

Maryland
      Johns Hopkins University (BPRU) Bayview Campus, Baltimore,  Maryland,  21224 6823,  United States

Study chairs or principal investigators

Eric C Strain, M.D.,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  NIDA-08045-4; R01-08045-4
Last Updated:  August 26, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00134914
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30