Drug Discrimination in Methadone-Maintained Humans Study 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Dependence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Receives 2-4 of the drugs listed under Intervention

Group Type EXPERIMENTAL

2-4 of the drugs listed below

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Cycloserine: Calan, Veralan Diltiazem: Cardizem Gabapentin: Neurontin Isradipine: DynaCirc Naloxone: Narca Nifedipine: Adalat, Procardia Placebo Saline Verapamil: Veralan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No