Drug Discrimination in Methadone-Maintained Humans Study 2

NCT00733239 | Completed Phase 1 DMC

• 4 other identifiers: R01DA010017-021048815R01DA010017-02DPMCDA
• Study Type: interventional
• Target: 15
• 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

Opioid Dependence

Keywords

methadone; opioid dependence; opioid

Outcome Measures

Primary Outcomes (1)

• Drug Discrimination Performance

  Every Session

Secondary Outcomes (3)

• Self-report Ratings

  Every Session

• Vital Signs

  Every Session

• ECG

  Test Sessions

Study Arms (1)

1

EXPERIMENTAL

Receives 2-4 of the drugs listed under Intervention

Drug: 2-4 of the drugs listed below

Interventions

2-4 of the drugs listed below DRUG

Cycloserine: 500, 675, 750 mg oral capsule may possibly be given Diltiazem: 30, 60, 120 mg oral capsule may possibly be given Gabapentin: 100, 200, 400 mg oral capsule may possibly be given Isradipine: 5, 10 mg oral capsule may possibly be given Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given Nifedipine: 5, 10, 20 mg oral capsule may possibly be given Placebo (sugar pill or microcrystalline cellulose): oral capsule may possibly be given Saline: I.M. injection may possibly be given Verapamil: 30, 60, 120 mg oral capsule may possibly be given

Also known as: Cycloserine: Calan, Veralan, Diltiazem: Cardizem, Gabapentin: Neurontin, Isradipine: DynaCirc, Naloxone: Narca, Nifedipine: Adalat, Procardia, Placebo, Saline, Verapamil: 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 month 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:

• Unstable medical condition or stable medical condition that would interact with study medications or participation.
• 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 (\< 1 week) use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested. Recent use will be defined based upon the pharmacokinetics of the drug and dosing schedule. Thus, a short-acting antihistamine taken as needed (e.g., once the night before) will not necessarily rule out a participant; however,
• 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 (ALT, AST) greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
• ECG abnormalities including but not limited to: bradycardia (\<60 bpm); 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
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Fitzgerald LR, Stanley NC, Guise JB, Cargile CS, Mancino MJ, Oliveto AH. Gabapentin and D-cycloserine alone and in combination with naloxone in methadone-maintained humans responding under a naloxone novel-response discrimination procedure. Behav Pharmacol. 2025 Aug 1;36(5):265-275. doi: 10.1097/FBP.0000000000000823. Epub 2025 Apr 8.

  PMID: 40272204 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Diltiazem; Gabapentin; Isradipine; Nifedipine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Alison Oliveto, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2008
• First Posted: August 13, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 18, 2012

Record last verified: 2012-04

Locations

US (1)