ClinicalTrials.gov
ClinicalTrials.gov Menu

Blockade Efficacy of Buprenorphine/Naloxone For Opioid Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00134888
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Brief Summary:
Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine/naloxone Not Applicable

Detailed Description:

Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals.

This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone
Study Start Date : December 2000
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Physiological effects [ Time Frame: up to one day ]
  2. drug effects (measured at Week 11) [ Time Frame: up to one day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets diagnostic criteria for opioid dependence
  • Qualifies for opioid substitution treatment (e.g., methadone)

Exclusion Criteria:

  • Significant psychiatric or physical disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134888


Locations
United States, Maryland
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, United States, 21224 6823
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Eric C. Strain, MD Johns Hopkins University

ClinicalTrials.gov Identifier: NCT00134888     History of Changes
Other Study ID Numbers: NIDA-08045-2
R01-08045-2
DPMC
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: July 2007

Keywords provided by National Institute on Drug Abuse (NIDA):
Opioid Dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists