Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
Primary Purpose
Opioid-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Buprenorphine and Naloxone
Hydromorphone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Opiate Addiction, Opiate Dependence
Eligibility Criteria
Inclusion Criteria: Current opioid abuse Not physically dependent on opioids Exclusion Criteria: Significant medical or psychiatric illness (e.g., insulin-dependent diabetes or schizophrenia) Seeking substance abuse treatment (will be assisted with referrals to community-based treatment programs) Pregnant
Sites / Locations
- Johns Hopkins University (BPRU) Bayview Campus
Outcomes
Primary Outcome Measures
Opioid agonist effects (measured by Visual Analog Scale and Adjective Rating Scale during the medication challenge sessions)
Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the medication challenge sessions)
Secondary Outcome Measures
Full Information
NCT ID
NCT00158236
First Posted
September 8, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00158236
Brief Title
Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
Official Title
Effects of Buprenorphine/Naloxone in Non-Dependent Opioid Abusers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
Buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. A buprenorphine and naloxone combination may reduce the likelihood of buprenorphine addiction. This study will evaluate the potential for abuse of buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.
Detailed Description
Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail. Individuals with severe opioid withdrawal may experience shaking, muscle and bone pain, nausea, depression, anxiety, and drug craving. Buprenorphine, a medication that is used to treat opioid addiction, works by lessening the withdrawal symptoms. However, past research has shown that individuals who use buprenorphine are at risk for abusing the drug. Naloxone, another medication, is currently used to treat substance addiction. It is also used in combination with buprenorphine to reduce the risk of buprenorphine abuse in individuals who are physically dependent upon opioids. The purpose of this study is to compare the abuse potential of buprenorphine versus a buprenorphine and naloxone combination in non-dependent opioid users.
This 7-week study will enroll non-dependent opioid users. Participants will take part in two medication challenge sessions per week. At each challenge session, participants will be randomly assigned to receive varying doses of either buprenorphine; a buprenorphine and naloxone combination; hydromorphone, which is a medication used to treat moderate to severe pain; or placebo. Buprenorphine and naloxone will be administered as tablets that are dissolved under the tongue. Hydromorphone will be injected. During the challenge sessions, participants will complete performance tasks to measure psychomotor and cognitive functioning. Questionnaires and self-reports will be completed to assess medication effects. Heart rate and blood pressure will be monitored throughout all sessions, and a specialized camera will be used to assess pupillary response of the eyes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
Opiate Addiction, Opiate Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
7 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Type
Drug
Intervention Name(s)
Buprenorphine and Naloxone
Intervention Type
Drug
Intervention Name(s)
Hydromorphone
Primary Outcome Measure Information:
Title
Opioid agonist effects (measured by Visual Analog Scale and Adjective Rating Scale during the medication challenge sessions)
Title
Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the medication challenge sessions)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current opioid abuse
Not physically dependent on opioids
Exclusion Criteria:
Significant medical or psychiatric illness (e.g., insulin-dependent diabetes or schizophrenia)
Seeking substance abuse treatment (will be assisted with referrals to community-based treatment programs)
Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C. Strain, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University (BPRU) Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224 6823
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10928310
Citation
Strain EC, Stoller K, Walsh SL, Bigelow GE. Effects of buprenorphine versus buprenorphine/naloxone tablets in non-dependent opioid abusers. Psychopharmacology (Berl). 2000 Mar;148(4):374-83. doi: 10.1007/s002130050066.
Results Reference
result
Learn more about this trial
Abuse Potential of Buprenorphine and Naloxone in Non-Dependent Opioid Users
We'll reach out to this number within 24 hrs