Buprenorphine is a treatment agent for opioid dependence which is combined with naloxone to minimize abuse potential. Although buprenorphine/naloxone is most often administered daily, this study examined the efficacy of various buprenorphine/naloxone doses given at less than daily intervals in preventing opioid withdrawal symptoms.

Condition	Intervention
Opioid-Related Disorders	Drug: Buprenorphine/naloxone

Further Study Details: 

Primary Outcomes: Physiological effects; Analog rating scale for drug effects
Expected Total Enrollment:  8

The purpose of this study was to assess the opioid blockade effects of buprenorphine/naloxone (B/N) over a time interval consistent with the probable clinical use of less than daily dosing. Opioid dependent volunteers (n=8) resided on a residential research unit for the duration of the 11-week study. Participants were maintained on three different dose levels of daily sublingual B/N (8/2, 16/4, 32/8 mg); order of the maintenance dose was randomized. After a minimum of two weeks on each maintenance dose, participants underwent challenge sessions on each weekday for one week (Monday through Friday). Challenges consisted of within-session ascending-dose administration of IM hydromorphone (H; 0, 6, and 12 mg). During that week active B/N dose was given only on Monday, and double blind placebo was administered on the remaining weekdays. Thus, challenge sessions tested the blockade effects at 2, 26, 50, 74, and 98 hours after the last active dose of B/N. Baseline participant- and observer-rated withdrawal taken at the start of challenge sessions increased across days of the week, but did not differ significantly as a function of B/N dose. During challenges, H dose, B/N dose and time since last B/N dose had a significant effect on pupil diameter. Magnitude of subjective response to H, however, was low, and was not related to B/N dose or time since last dose. These results support the use of less than daily dosing of sublingual B/N, even at relatively low doses.

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

Accepts Healthy Volunteers

Criteria

Males and females with active opioid dependence.

Inclusion Criteria:

Must qualify for opioid subsitution treatment (i.e. methadone) and must fulfill the diagnostic criteria for opioid dependence.

Exclusion Criteria:

Volunteers must be free of significant psychiatric or physical disorders.

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-08045-2; R01-08045-2
Last Updated:  August 26, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00134888
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30