Drug Discrimination in Methadone-Maintained Humans Study 2 (OMDD2)
This study has been completed.
Sponsor:
University of Arkansas
Collaborator:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00733239
First received: August 11, 2008
Last updated: April 16, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|---|
|
Opioid Dependence |
Drug: 2-4 of the drugs listed below |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Drug Discrimination in Methadone-Maintained Humans Study 2 |
Resource links provided by NLM:
Drug Information available for:
Cycloserine
Methadone
Verapamil hydrochloride
Naloxone hydrochloride
Methadone hydrochloride
Nifedipine
Diltiazem hydrochloride
Diltiazem
Gabapentin
Isradipine
Diltiazem malate
Gabapentin enacarbil
U.S. FDA Resources
Further study details as provided by University of Arkansas:
Primary Outcome Measures:
- Drug Discrimination Performance [ Time Frame: Every Session ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Self-report Ratings [ Time Frame: Every Session ] [ Designated as safety issue: No ]
- Vital Signs [ Time Frame: Every Session ] [ Designated as safety issue: Yes ]
- ECG [ Time Frame: Test Sessions ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Receives 2-4 of the drugs listed under Intervention
|
Drug: 2-4 of the drugs listed below
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
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733239
Locations
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
Sponsors and Collaborators
University of Arkansas
Investigators
| Principal Investigator: | Alison Oliveto, Ph.D. | University of Arkansas |
More Information
No publications provided
| Responsible Party: | University of Arkansas |
| ClinicalTrials.gov Identifier: | NCT00733239 History of Changes |
| Other Study ID Numbers: | R01-DA010017-02, R01DA010017-02, 104881, 5 R01 DA010017-02, DPMCDA |
| Study First Received: | August 11, 2008 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Arkansas:
|
methadone opioid dependence opioid |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Diltiazem Verapamil Nifedipine Gabapentin Isradipine Cycloserine Methadone Naloxone Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Vasodilator Agents Anti-Arrhythmia Agents Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antibiotics, Antitubercular Anti-Bacterial Agents Antitubercular Agents Antimetabolites Analgesics, Opioid Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013