Drug Discrimination in Methadone-Maintained Humans Study 2

Opioid Dependence Clinical Trial

— OMDD2  

Official title:

Drug Discrimination in Methadone-Maintained Humans Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733239
• Other study ID #: R01DA010017-02
• Secondary ID: R01DA010017-0210
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2008
• Last updated: April 16, 2012
• Start date: August 2008
• Est. completion date: October 2010

Study information

• Verified date: April 2012
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Discrimination Performance		Every Session	No
Secondary	Self-report Ratings		Every Session	No
Secondary	Vital Signs		Every Session	Yes
Secondary	ECG		Test Sessions	Yes