- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593463
Drug Discrimination in Methadone-Maintained Humans Study 1 (OMDD1)
March 10, 2011 updated by: University of Arkansas
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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.
Exclusion Criteria:
Exclusion criteria
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Receives 2-4 of the interventions listed
|
Cycloserine: 500, 675, 750 mg oral capsule may possibly be given
Other Names:
Diltiazem: 30, 60, 120 mg oral capsule may possibly be
Other Names:
Gabapentin: 100, 200, 400 mg oral capsule may possibly be given
Other Names:
Isradipine: 5, 10 mg oral capsule may possibly be given
Other Names:
Naloxone: 0.15 mg/70 kg or 0.2 mg I.M. injection may possibly be given
Other Names:
Nifedipine: 5, 10, 20 mg oral capsule may possibly be given
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug Discrimination Measure
Time Frame: Every session
|
Every session
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Self-reported effects
Time Frame: Every Session
|
Every Session
|
Vital Signs
Time Frame: Every session
|
Every session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
January 4, 2008
First Submitted That Met QC Criteria
January 4, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
March 11, 2011
Last Update Submitted That Met QC Criteria
March 10, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Antimetabolites
- Anti-Bacterial Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Narcotic Antagonists
- Anticonvulsants
- Antimanic Agents
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Antitubercular Agents
- Tocolytic Agents
- Antibiotics, Antitubercular
- Anti-Infective Agents, Urinary
- Renal Agents
- Gabapentin
- Naloxone
- Nifedipine
- Cycloserine
- Verapamil
- Diltiazem
- Isradipine
Other Study ID Numbers
- R01DA010017-01 (U.S. NIH Grant/Contract)
- DPMC (Other Identifier: NIDA)
- 57184
- R01DA010017 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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