Drug Discrimination in Methadone-Maintained Humans Study 1

NCT00593463 | Completed Phase 1 DMC

• 4 other identifiers: R01DA010017-0157184R01DA010017DPMC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Dependence

Keywords

opioid dependence; methadone; opioid

Outcome Measures

Primary Outcomes (1)

• Drug Discrimination Measure

  Every session

Secondary Outcomes (2)

• Self-reported effects

  Every Session

• Vital Signs

  Every session

Study Arms (1)

1

EXPERIMENTAL

Receives 2-4 of the interventions listed

Drug: Cycloserine; Drug: Diltiazem; Drug: Gabapentin; Drug: Isradipine; Drug: Naloxone; Drug: Nifedipine; Drug: Placebo; Device: Saline; Drug: Verapamil

Interventions

Cycloserine DRUG

Cycloserine: 500, 675, 750 mg oral capsule may possibly be given

Also known as: Calan, Veralan

1

Diltiazem DRUG

Diltiazem: 30, 60, 120 mg oral capsule may possibly be

Also known as: Cardizem

1

Gabapentin DRUG

Gabapentin: 100, 200, 400 mg oral capsule may possibly be given

Also known as: Neurontin

1

Isradipine DRUG

Isradipine: 5, 10 mg oral capsule may possibly be given

Also known as: DynaCirc

1

Naloxone DRUG

Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given

Also known as: Narca

1

Nifedipine DRUG

Nifedipine: 5, 10, 20 mg oral capsule may possibly be given

Also known as: Adalat, Procardia

1

Placebo DRUG

Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given

1

Saline DEVICE

Saline: I.M. injection may possibly be given

1

Verapamil DRUG

Verapamil: 30, 60, 120 mg oral capsule may possibly be given

Also known as: Veralan

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be between the ages of 18-65.
• 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.
• 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
• Subjects must submit a urine sample negative for illicit drugs prior to study entry.
• Subjects must be able to read and understand English.

You may not qualify if:

• Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below).
• Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
• History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
• Pregnancy, plans to become pregnant or inadequate birth control.
• 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.
• 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.
• Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders

Interventions

Cycloserine; Verapamil; Diltiazem; Gabapentin; Isradipine; Naloxone; Nifedipine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Dihydropyridines; Pyridines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Alison Oliveto, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 15, 2008
• Study Start: September 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 11, 2011

Record last verified: 2011-03

Locations

US (1)