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Drug Discrimination in Methadone-Maintained Humans Study 1 (OMDD1)

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00593463
First received: January 4, 2008
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
  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 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

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
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receives 2-4 of the interventions listed
 Drug: Cycloserine
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
Other Names:
  • Calan
  • Veralan
Drug: Diltiazem
Diltiazem: 30, 60, 120 mg oral capsule may possibly be
Other Name: Cardizem
Drug: Gabapentin
Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
Other Name: Neurontin
Drug: Isradipine
Isradipine: 5, 10 mg oral capsule may possibly be given
Other Name: DynaCirc
Drug: Naloxone
Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
Other Name: Narca
Drug: Nifedipine
Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
Other Names:
  • Adalat
  • Procardia
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
Other Name: Veralan

  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

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Alison Oliveto, PhD University of Arkansas
  More Information

No publications provided

Responsible Party: Alison Oliveto, Ph.D./Principal Investigator, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00593463     History of Changes
Other Study ID Numbers: R01-DA010017-01, 57184, R01DA010017, DPMC
Study First Received: January 4, 2008
Last Updated: March 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
opioid dependence
methadone
opioid

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Diltiazem
Verapamil
Nifedipine
Gabapentin
Isradipine
Cycloserine
Methadone
Naloxone
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
 Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Anti-Arrhythmia Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013