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

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.
 
ClinicalTrials.gov Identifier: NCT00593463
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : March 11, 2011
Sponsor:
Information provided by:
University of Arkansas

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Drug Dependence Drug: Cycloserine Drug: Diltiazem Drug: Gabapentin Drug: Isradipine Drug: Naloxone Drug: Nifedipine Drug: Placebo Device: Saline Drug: Verapamil Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Drug Discrimination in Methadone-Maintained Humans Study 1
Study Start Date : September 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines
Drug Information available for: Methadone

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 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
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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): NCT00593463


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Alison Oliveto, PhD University of Arkansas
More Information
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Responsible Party: Alison Oliveto, Ph.D./Principal Investigator, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00593463    
Other Study ID Numbers: R01DA010017-01 ( U.S. NIH Grant/Contract )
57184
R01DA010017 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: March 2011
Keywords provided by University of Arkansas:
opioid dependence
methadone
opioid
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cycloserine
Verapamil
Diltiazem
Isradipine
Nifedipine
Gabapentin
Naloxone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
 Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Narcotic Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Tocolytic Agents