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Drug Discrimination in Methadone-Maintained Humans Study 2 (OMDD2)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), March 2009
First Received: August 11, 2008   Last Updated: March 10, 2009   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Arkansas
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00733239
  Purpose

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.


Condition Intervention Phase
Opioid Dependence
Drug: 2-4 of the drugs listed below
Phase I

Drug Information available for: Verapamil Cycloserine Nifedipine Diltiazem hydrochloride Dexverapamil Diltiazem Gabapentin Isradipine Methadone Diltiazem malate Verapamil hydrochloride Naloxone Methadone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Double Blind (Subject, Investigator), Single Group Assignment
Official Title: Drug Discrimination in Methadone-Maintained Humans Study 2

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Drug Discrimination Performance [ Time Frame: Every Session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-report Ratings [ Time Frame: Every Session ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Every Session ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Test Sessions ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Receives 2-4 of the drugs listed under 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733239

Contacts
Contact: Paula Duke, RN, MA 501-526-8447 DukePaulaL@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alison Oliveto     501-686-8969     olivetoalison@uams.edu    
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Alison Oliveto, Ph.D. University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas for Medical Sciences ( Alison Oliveto, Ph.D./Principal Investigator )
Study ID Numbers: R01-DA010017-02, 104881, 5 R01 DA010017-02
Study First Received: August 11, 2008
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00733239     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
methadone
opioid dependence
opioid

Study placed in the following topic categories:
Antimetabolites
Cycloserine
Gabapentin
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Anti-Infective Agents, Urinary
Opioid-Related Disorders
Nifedipine
Isradipine
Naloxone
Naphazoline
Anti-Bacterial Agents
Methadone
Verapamil
Guaifenesin
Mental Disorders
Diltiazem
Substance-Related Disorders
Peripheral Nervous System Agents
Analgesics
Phenylpropanolamine
Antitubercular Agents
Analgesics, Opioid

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Respiratory System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Renal Agents
Opioid-Related Disorders
Anti-Bacterial Agents
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Analgesics, Opioid
Cycloserine
Central Nervous System Depressants
Anti-Infective Agents, Urinary
Narcotics
Pharmacologic Actions
Antibiotics, Antitubercular
Methadone
Antitubercular Agents
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009