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Drug Discrimination in Methadone-Maintained Humans
This study is currently recruiting participants.
Verified by University of Arkansas, January 2008
Sponsors and Collaborators: University of Arkansas
National Institute on Drug Abuse (NIDA)
Information provided by: University of Arkansas
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
Methadone-Maintained Addiction
Drug: Naloxone
Drug: Saline
Drug: Diltiazem
Drug: Verapamil
Drug: Cycloserine
Drug: Gabapentin
Drug: Isradipine
Drug: Nifedipine
Drug: Sugar Pill
Phase II

Drug Information available for: Methadone Methadone hydrochloride Cycloserine Nifedipine Naloxone Naloxone hydrochloride Gabapentin Diltiazem Verapamil Dexverapamil Diltiazem hydrochloride Diltiazem malate Verapamil hydrochloride Isradipine
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title: Drug Discrimination in Methadone-Maintained Humans Study 1

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Drug Discrimination Measure [ Time Frame: 3-5 times/week for duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2006
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
2: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
3: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
4: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
5: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
6: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
7: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg oral capsule may possibly be given
8: Experimental
Receives 2-4 of the interventions listed
Drug: Naloxone
Training phase 0.15mg/70kg IM
Drug: Saline
Training phase 0.15mg/70kg intramuscular injection up to 0.20 mg
Drug: Naloxone
Discrimination Phase: 0.075, 0.15, 0.2mg/70 kg intramuscular injection alone and in combination with other interventions may possibly be given
Drug: Diltiazem
Discrimination Phase: 30, 60, or 120 mg/70 kg oral capsule may possibly be given
Drug: Verapamil
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Cycloserine
Discrimination Phase: 30, 60, 120mg/70 kg oral capsule may possibly be given
Drug: Gabapentin
Discrimination Phase: 30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Isradipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Nifedipine
30, 60, 120 mg/70 kg oral capsule may possibly be given
Drug: Sugar Pill
30, 60, 120 mg/70 kg 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: Julie Owens 501-686-5801 OwensJulie@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alison Oliveto, PhD     501-686-8969     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

Responsible Party: University of Arkansas for Medical Sciences ( Carole Hamon )
Study ID Numbers: 57184
Study First Received: January 4, 2008
Last Updated: January 4, 2008
ClinicalTrials.gov Identifier: NCT00593463  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by University of Arkansas:
drug abuse
addiction
methadone
opioid

Study placed in the following topic categories:
Cycloserine
Excitatory Amino Acids
Behavior, Addictive
Gabapentin
Nifedipine
Isradipine
Naloxone
Naphazoline
Calcium, Dietary
Methadone
Oxymetazoline
Verapamil
Guaifenesin
Phenylephrine
Diltiazem
Phenylpropanolamine

Additional relevant MeSH terms:
Antimetabolites
Respiratory System Agents
Anti-Infective Agents
Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Narcotic Antagonists
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Reproductive Control Agents
Renal Agents
Membrane Transport Modulators
Anti-Bacterial Agents
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Analgesics, Opioid
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Anti-Infective Agents, Urinary
Narcotics
Cardiovascular Agents
Antihypertensive Agents
Antimanic Agents

ClinicalTrials.gov processed this record on January 16, 2009