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Drug Discrimination in Methadone-Maintained Humans Study 2 (OMDD2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733239
First Posted: August 13, 2008
Last Update Posted: April 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Arkansas
  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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Drug Discrimination in Methadone-Maintained Humans Study 2

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Drug Discrimination Performance [ Time Frame: Every Session ]

Secondary Outcome Measures:
  • Self-report Ratings [ Time Frame: Every Session ]
  • Vital Signs [ Time Frame: Every Session ]
  • ECG [ Time Frame: Test Sessions ]

Enrollment: 15
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Other Names:
  • Cycloserine: Calan, Veralan
  • Diltiazem: Cardizem
  • Gabapentin: Neurontin
  • Isradipine: DynaCirc
  • Naloxone: Narca
  • Nifedipine: Adalat, Procardia
  • Placebo
  • Saline
  • Verapamil: Veralan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733239


Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Alison Oliveto, Ph.D. University of Arkansas
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00733239     History of Changes
Other Study ID Numbers: R01DA010017-02 ( U.S. NIH Grant/Contract )
104881
5R01DA010017-02 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: August 11, 2008
First Posted: August 13, 2008
Last Update Posted: April 18, 2012
Last Verified: April 2012

Keywords provided by University of Arkansas:
methadone
opioid dependence
opioid

Additional relevant MeSH terms:
Gabapentin
Methadone
Nifedipine
Verapamil
Diltiazem
Isradipine
Naloxone
Cycloserine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
Analgesics, Opioid
Narcotics
Antitussive Agents
Respiratory System Agents