Official Title: “Drug Discrimination in Methadone-Maintained Humans Study 2”

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.

Study Type: Interventional

Study Design: Basic Science, Double Blind (Subject, Investigator), Single Group Assignment

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: 2-4 of the drugs listed below
  • Cycloserine: 500, 675, 750 mg oral capsule may possibly be given Diltiazem: 30, 60, 120 mg oral capsule may possibly be given Gabapentin: 100, 200, 400 mg oral capsule may possibly be given Isradipine: 5, 10 mg oral capsule may possibly be given Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given Nifedipine: 5, 10, 20 mg oral capsule may possibly be given Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given Saline: I.M. injection may possibly be given Verapamil: 30, 60, 120 mg oral capsule may possibly be given

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Receives 2-4 of the drugs listed under Intervention

Primary Measures

• Drug Discrimination Performance
  • Time Frame: Every Session
    Safety Issue?: No

Secondary Measures

• Self-report Ratings
  • Time Frame: Every Session
    Safety Issue?: No
• Vital Signs
  • Time Frame: Every Session
    Safety Issue?: Yes
• ECG
  • Time Frame: Test Sessions
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute on Drug Abuse (NIDA)

Overall Clinical Trial Officials and Contacts

Alison Oliveto, Ph.D. Principal Investigator University of Arkansas  

Overall Contact: Paula Duke, RN, MA 501-526-8447 DukePaulaL@uams.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00733239

Study ID Number: R01-DA010017-02

ClinicalTrials.gov Identifier: NCT00733239

Health Authority: United States: Food and Drug Administration