Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
University of Arkansas Identifier:
First received: January 4, 2008
Last updated: March 10, 2011
Last verified: March 2011
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 (Participant, Investigator)
Official Title: Drug Discrimination in Methadone-Maintained Humans Study 1

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Drug Discrimination Measure [ Time Frame: Every session ]

Secondary Outcome Measures:
  • Self-reported effects [ Time Frame: Every Session ]
  • Vital Signs [ Time Frame: Every session ]

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00593463

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

Responsible Party: Alison Oliveto, Ph.D./Principal Investigator, University of Arkansas for Medical Sciences Identifier: NCT00593463     History of Changes
Other Study ID Numbers: R01DA010017-01 ( US NIH Grant/Contract Award Number )
R01DA010017 ( US NIH Grant/Contract Award Number )
DPMC ( Other Identifier: NIDA )
Study First Received: January 4, 2008
Last Updated: March 10, 2011

Keywords provided by University of Arkansas:
opioid dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites processed this record on April 24, 2017