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Completed

NCT Number: NCT00733239

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be between the ages of 18-65.
  • 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.
  • 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
  • Subjects must submit a urine sample negative for illicit drugs prior to study entry.
  • Subjects must be able to read and understand English.

Exclusion criteria

  • Unstable medical condition or stable medical condition that would interact with study medications or participation.
  • Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
  • History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
  • Pregnancy, plans to become pregnant or inadequate birth control.
  • 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,
  • 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.
  • Liver function tests (ALT, AST) greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
  • 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.

Treatment and study plan

2-4 of the drugs listed below

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

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

Primary outcomes

  1. Drug Discrimination Performance

    Time frame: Every Session

Secondary outcomes

  1. Self-report Ratings

    Time frame: Every Session

  2. Vital Signs

    Time frame: Every Session

  3. ECG

    Time frame: Test Sessions

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: OMDD2

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2008
Registry last updated
Apr 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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