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Drug Discrimination in Methadone-Maintained Humans Study 2 (OMDD2)

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
2-4 of the drugs listed below
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opioid Dependence focused on measuring methadone, opioid dependence, opioid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 month 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:

  1. Unstable medical condition or stable medical condition that would interact with study medications or participation.
  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 (< 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,
  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 (ALT, AST) greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
  8. 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.

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Receives 2-4 of the drugs listed under Intervention

Outcomes

Primary Outcome Measures

Drug Discrimination Performance

Secondary Outcome Measures

Self-report Ratings
Vital Signs
ECG

Full Information

First Posted
August 11, 2008
Last Updated
April 16, 2012
Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00733239
Brief Title
Drug Discrimination in Methadone-Maintained Humans Study 2
Acronym
OMDD2
Official Title
Drug Discrimination in Methadone-Maintained Humans Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence
Keywords
methadone, opioid dependence, opioid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Receives 2-4 of the drugs listed under Intervention
Intervention Type
Drug
Intervention Name(s)
2-4 of the drugs listed below
Other Intervention Name(s)
Cycloserine: Calan, Veralan, Diltiazem: Cardizem, Gabapentin: Neurontin, Isradipine: DynaCirc, Naloxone: Narca, Nifedipine: Adalat, Procardia, Placebo, Saline, Verapamil: Veralan
Intervention Description
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
Primary Outcome Measure Information:
Title
Drug Discrimination Performance
Time Frame
Every Session
Secondary Outcome Measure Information:
Title
Self-report Ratings
Time Frame
Every Session
Title
Vital Signs
Time Frame
Every Session
Title
ECG
Time Frame
Test Sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Oliveto, Ph.D.
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Drug Discrimination in Methadone-Maintained Humans Study 2

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