Drug Discrimination in Methadone-Maintained Humans
Information source: University of Arkansas
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methadone-Maintained Addiction
Intervention: Naloxone (Drug); Saline (Drug); Naloxone (Drug); Diltiazem (Drug); Verapamil (Drug); Cycloserine (Drug); Gabapentin (Drug); Isradipine (Drug); Nifedipine (Drug); Sugar Pill (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s):
Alison Oliveto, PhD, Principal Investigator, Affiliation: University of Arkansas
Overall contact:
Julie Owens, Phone: 501-686-5801, Email: OwensJulie@uams.edu
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 1
Study design: Other, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Primary outcome: Drug Discrimination Measure
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 two months 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:
Exclusion criteria
1. Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined
by history provided by the prospective subject or laboratory evaluation as outlined
below).
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 use of over-the-counter psychoactive drug, prescription psychoactive
drug or drug that would have major interaction with drugs to be tested.
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 greater than 3 times normal, BUN and Creatinine outside normal
range, or thyroid function tests outside normal range.
8. EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged with
QTc interval (>420 msec); 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
Julie Owens, Phone: 501-686-5801, Email: OwensJulie@uams.edu
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States; Recruiting
Alison Oliveto, PhD, Phone: 501-686-8969, Email: OlivetoAlison@uams.edu
Alison Oliveto, PhD, Principal Investigator
Additional Information
Starting date: September 2006
Ending date: January 2010
Last updated: January 4, 2008
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