Effects of Buprenorphine/Naloxone Administered in Different Ways For Treating Opioid Dependence

Opioid-Related Disorders Clinical Trial

Official title:

Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134914
• Other study ID #: NIDA-08045-4
• Secondary ID: R01-08045-4DPMC
• Status: Completed
• Phase: N/A
• First received: August 23, 2005
• Last updated: January 11, 2017
• Start date: August 1996
• Est. completion date: May 1998

Study information

• Verified date: July 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1998
• Est. primary completion date: April 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Currently opioid dependent

• In good health, as determined by a pre-participation medical examination

• Seeking and eligible for methadone maintenance or detoxification treatment

Exclusion Criteria:

• Significant medical or psychiatric illness, other than drug dependence

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine
single doses given by sublingual and parenteral routes

Locations

Country	Name	City	State
United States	Johns Hopkins University (BPRU) Bayview Campus	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Stoller KB, Bigelow GE, Walsh SL, Strain EC. Effects of buprenorphine/naloxone in opioid-dependent humans. Psychopharmacology (Berl). 2001 Mar;154(3):230-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid agonist rating		up to one day	Yes
Primary	opiate withdrawal		up to one day	Yes
Primary	physiologic measures		up to one day	Yes