Status:
COMPLETED
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Abuse
Opioid Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggest...
Eligibility Criteria
Inclusion
- Be adults ranging in age from 21-55 years old.
- Be dependent on opioids.
- Be willing to accept or desiring of opioid detoxification.
- He healthy as determined by medical screen, history, and vitals.
- Be without significant psychiatric illness besides drug dependence.
- Be without chronic pain.
- Fluent in English (speaking, writing, and reading).
- Be willing and able to participate.
Exclusion
- Previous documented allergy to buprenorphine or morphine.
- Are dependent on other drugs besides opioids and tobacco.
- Have current history of significant use of alcohol or sedative/hypnotics.
- Have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.
- Are pregnant (female volunteers will receive a pregnancy test before participation in the study and routinely during the study).
- Have an abnormal or prolongation of the corrected QT interval (QTc) on a baseline electrocardiogram (ECG).
- Are seeking treatment for their substance dependence.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01136356
Start Date
July 1 2010
End Date
March 1 2012
Last Update
March 3 2017
Active Locations (1)
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1
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224