Status:
COMPLETED
Drug Discrimination in Methadone-Maintained Humans Study 2
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between o...
Eligibility Criteria
Inclusion
- Must be between the ages of 18-65.
- Participation in the UAMS Substance Abuse Treatment Clinic Methadone Maintenance Program or the Catar Clinic Little Rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry.
- Subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. This would be defined as \< 3 missed methadone medications and missed \< 3 group or \<3 individual therapy sessions in the month prior to study participation
- Subjects must submit a urine sample negative for illicit drugs prior to study entry.
- Subjects must be able to read and understand English.
Exclusion
- Unstable medical condition or stable medical condition that would interact with study medications or participation.
- Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
- History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
- Pregnancy, plans to become pregnant or inadequate birth control.
- Present or recent (\< 1 week) use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested. Recent use will be defined based upon the pharmacokinetics of the drug and dosing schedule. Thus, a short-acting antihistamine taken as needed (e.g., once the night before) will not necessarily rule out a participant; however,
- History of severe reaction to Narcan challenge, which may have been given as part of admission into the Methadone Maintenance Program or to reverse overdose.
- Liver function tests (ALT, AST) greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
- ECG abnormalities including but not limited to: bradycardia (\<60 bpm); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00733239
Start Date
August 1 2008
End Date
October 1 2010
Last Update
April 18 2012
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205