Drug Discrimination in Methadone-Maintained Humans Study 2
Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid Dependence
Intervention: 2-4 of the drugs listed below (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s): Alison Oliveto, Ph.D., Principal Investigator, Affiliation: University of Arkansas
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 one drug and another, as well as measuring the effects of the drugs on
mood, physiology (e. g., heart rate, blood pressure, respiration rate) and behavior. Each
subject will receive 2-4 of the listed interventions.
Clinical Details
Official title: Drug Discrimination in Methadone-Maintained Humans Study 2
Study design: Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Drug Discrimination Performance
Secondary outcome: Self-report RatingsVital Signs ECG
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Must be between the ages of 18-65.
2. 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.
3. 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
4. Subjects must submit a urine sample negative for illicit drugs prior to study entry.
5. Subjects must be able to read and understand English.
Exclusion Criteria:
1. Unstable medical condition or stable medical condition that would interact with study
medications or participation.
2. Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
3. History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
4. Pregnancy, plans to become pregnant or inadequate birth control.
5. 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,
6. 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.
7. Liver function tests (ALT, AST) greater than 3 times normal, BUN and Creatinine
outside normal range, or thyroid function tests outside normal range.
8. 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.
Locations and Contacts
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Additional Information
Starting date: August 2008
Last updated: April 16, 2012
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