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OpenTrials
Completed

NCT Number: NCT00134914

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

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.

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Key information

Conditions

Opioid-related Disorders Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University (BPRU) Bayview Campus

Baltimore, Maryland, 21224 6823, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

single doses given by sublingual and parenteral routes

Primary outcomes

  1. Opioid agonist rating

    Time frame: up to one day

  2. opiate withdrawal

    Time frame: up to one day

  3. physiologic measures

    Time frame: up to one day

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals

Important dates

Study start
1996
Primary completion
1998
Study completion
1998
First posted
Aug 25, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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