Skip to content

Drug Discrimination in Methadone-Maintained Humans Study 1

Drug Discrimination in Methadone-Maintained Humans Study 1

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00593463
Acronym
OMDD1
Enrollment
40
Registered
2008-01-15
Start date
2006-09-30
Completion date
2010-05-31
Last updated
2011-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Dependence

Keywords

opioid dependence, methadone, opioid

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.

Interventions

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

DRUGDiltiazem

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

DRUGGabapentin

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

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

DRUGNaloxone

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

DRUGNifedipine

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

DRUGPlacebo

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

DEVICESaline

Saline: I.M. injection may possibly be given

DRUGVerapamil

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

Sponsors

University of Arkansas
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Drug Discrimination MeasureEvery session

Secondary

MeasureTime frame
Self-reported effectsEvery Session
Vital SignsEvery session

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026