Full Text View
Tabular View
No Study Results Posted
Related Studies
Drug Discrimination in Methadone-Maintained Humans Study 1 (OMDD1)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), November 2009
First Received: January 4, 2008   Last Updated: November 24, 2009   History of Changes
Sponsor: National Institute on Drug Abuse (NIDA)
Collaborator: University of Arkansas
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00593463
  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
Drug Dependence
Drug: Cycloserine
Drug: Diltiazem
Drug: Gabapentin
Drug: Isradipine
Drug: Naloxone
Drug: Nifedipine
Drug: Placebo
Device: Saline
Drug: Verapamil
Phase I

Study Type: Interventional
Study Design: Double Blind (Subject, Investigator), Single Group Assignment
Official Title: Drug Discrimination in Methadone-Maintained Humans Study 1

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Self-reported effects [ Time Frame: Every Session ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: Every session ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: September 2006
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Receives 2-4 of the interventions listed
Drug: Cycloserine
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
Drug: Diltiazem
Diltiazem: 30, 60, 120 mg oral capsule may possibly be
Drug: Gabapentin
Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
Drug: Isradipine
Isradipine: 5, 10 mg oral capsule may possibly be given
Drug: Naloxone
Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
Drug: Nifedipine
Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
Drug: Placebo
Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given
Device: Saline
Saline: I.M. injection may possibly be given
Drug: Verapamil
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 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:

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593463

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

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alison Oliveto, PhD     501-526-8441     OlivetoAlison@uams.edu    
Principal Investigator: Alison Oliveto, PhD            
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Alison Oliveto, PhD 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-DA010017-01, 57184, R01DA010017, DPMC
Study First Received: January 4, 2008
Last Updated: November 24, 2009
ClinicalTrials.gov Identifier: NCT00593463     History of Changes
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Anti-Infective Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Excitatory Amino Acid Agents
Renal Agents
Isradipine
Membrane Transport Modulators
Therapeutic Uses
Substance-Related Disorders
Tranquilizing Agents
Anti-Infective Agents, Urinary
Narcotics
Antihypertensive Agents
Verapamil
Diltiazem
Anti-Anxiety Agents
Antitubercular Agents
Antitussive Agents
Antimetabolites
Respiratory System Agents
Vasodilator Agents
Narcotic Antagonists
Psychotropic Drugs
Disorders of Environmental Origin
Antiparkinson Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on November 27, 2009