- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01068847
Drug Discrimination in Methadone-Maintained Humans Study 3 (OMDD3)
March 6, 2013 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 participant'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 participant will receive 2-4 of the listed interventions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
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 and <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:
- Unstable medical condition (e.g., major, unstable cardiovascular, renal, endocrine or hepatic disease) or stable medical condition requiring treatment that would interact with study medications (e.g., controlled hypertension on an antihypertensive) or ability to participate in study sessions, (e.g.,chronic back pain that would preclude being able to sit for long periods, etc), to be determined by history provided by the prospective subject or laboratory evaluation and physical examination as outlined below. These would be determined by the study physician alone or in consultation with the PI.
- Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
- History of major psychiatric disorder (psychosis, schizophrenia, bipolar) or current psychiatric disorder that requires medication (e.g., current major depression).
- Pregnancy, plans to become pregnant or inadequate birth control (adequate birth control includes an IUD, condoms, birth control pills, etc). Male participants are encouraged to use condoms because little has been studied on the effects of these drugs on the male reproductive system.
- Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug (antidepressants, anxiolytics, antipsychotics and anticonvulsants that may also be used for mood stabilization or sleep disruption) or drug (e.g., ciprofloxacin, fluvoxamine) that would have major interaction with drugs to be tested.
- Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
- A supine or semi-recumbent blood pressure of 100/65mmHg, a seated blood pressure of 90/60mmHg, or orthostatic change of >20mmHg systolic or >10mmHg diastolic on standing or heart rate less than 60 beats/min.
- EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 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.
- Participants who become arrested and/or incarcerated will not be allowed to continue to participate.
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
- Primary Purpose: Basic Science
- 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 drugs listed under Intervention
|
Cycloserine: 500, 675, 750 mg oral capsules may possibly given.
Naloxone: 0.15mg/70Kg or 0.2mg/70kg I.M. injection may possibly be given.
Nifedipine: 10, 20 mg oral capsules may possibly be given.
Placebo (sugar pill or microcrystalline cellulose): oral capsules may be given.
Saline: I.M. injection may possibly be given.
Tizanidine: 4, 8, 12 mg oral capsules may possibly be given.
Verapamil: 30, 60, 120 mg oral capsules may possibly be given.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug Discrimination Performance
Time Frame: Every Session
|
Every Session
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ECG
Time Frame: Test Sessions
|
Test Sessions
|
Vital Signs
Time Frame: Every session
|
Every session
|
Self-Report Ratings
Time Frame: Every Session
|
Every Session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alison Oliveto, Ph.D., University of Arkansas
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
February 1, 2010
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
February 12, 2010
First Submitted That Met QC Criteria
February 12, 2010
First Posted (Estimate)
February 15, 2010
Study Record Updates
Last Update Posted (Estimate)
March 7, 2013
Last Update Submitted That Met QC Criteria
March 6, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Anti-Infective Agents
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Antimetabolites
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anti-Bacterial Agents
- Membrane Transport Modulators
- Narcotic Antagonists
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Neuromuscular Agents
- Antitubercular Agents
- Tocolytic Agents
- Antibiotics, Antitubercular
- Muscle Relaxants, Central
- Anti-Infective Agents, Urinary
- Renal Agents
- Naloxone
- Nifedipine
- Cycloserine
- Verapamil
- Tizanidine
Other Study ID Numbers
- R01DA010017-03 (U.S. NIH Grant/Contract)
- DPMC (Other Identifier: NIDA)
- R01DA010017 (U.S. NIH Grant/Contract)
- 110528
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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