Drug Discrimination in Methadone-Maintained Humans Study 1

NCT ID: NCT00593463

Last Updated: 2011-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2010-05-31

Brief 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.

Conditions

Drug Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: DOUBLE

Study Groups

1

Receives 2-4 of the interventions listed

Group Type: EXPERIMENTAL

Cycloserine

Intervention Type: DRUG

Cycloserine: 500, 675, 750 mg oral capsule may possibly be given

Diltiazem

Intervention Type: DRUG

Diltiazem: 30, 60, 120 mg oral capsule may possibly be

Gabapentin

Intervention Type: DRUG

Gabapentin: 100, 200, 400 mg oral capsule may possibly be given

Isradipine

Intervention Type: DRUG

Isradipine: 5, 10 mg oral capsule may possibly be given

Naloxone

Intervention Type: DRUG

Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given

Nifedipine

Intervention Type: DRUG

Nifedipine: 5, 10, 20 mg oral capsule may possibly be given

Placebo

Intervention Type: DRUG

Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given

Saline

Intervention Type: DEVICE

Saline: I.M. injection may possibly be given

Verapamil

Intervention Type: DRUG

Verapamil: 30, 60, 120 mg oral capsule may possibly be given

Interventions

Cycloserine

Cycloserine: 500, 675, 750 mg oral capsule may possibly be given

Intervention Type: DRUG

Diltiazem

Diltiazem: 30, 60, 120 mg oral capsule may possibly be

Intervention Type: DRUG

Gabapentin

Gabapentin: 100, 200, 400 mg oral capsule may possibly be given

Intervention Type: DRUG

Isradipine

Isradipine: 5, 10 mg oral capsule may possibly be given

Intervention Type: DRUG

Naloxone

Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given

Intervention Type: DRUG

Nifedipine

Nifedipine: 5, 10, 20 mg oral capsule may possibly be given

Intervention Type: DRUG

Placebo

Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given

Intervention Type: DRUG

Saline

Saline: I.M. injection may possibly be given

Intervention Type: DEVICE

Verapamil

Verapamil: 30, 60, 120 mg oral capsule may possibly be given

Intervention Type: DRUG

Other Intervention Names

Calan; Veralan; Cardizem; Neurontin; DynaCirc; Narca; Adalat; Procardia; Veralan

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

University of Arkansas for Medical Sciences

Principal Investigators

Alison Oliveto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

57184

Identifier Type: -

Identifier Source: secondary_id

R01DA010017

Identifier Type: NIH

Identifier Source: secondary_id

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DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

R01DA010017-01

Identifier Type: NIH

Identifier Source: org_study_id

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