Status:
COMPLETED
Improving Buprenorphine Detoxification Outcomes With Isradipine
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This application seeks to address the problem of opioid withdrawal by examining the utility of the L-type calcium channel blocker (CCB) isradipine as an adjunct to BUP detoxification. This project wil...
Detailed Description
Opioid dependence continues to be a serious public health problem, particularly with the dramatic rise in prescription opioid abuse. Traditional methods of detoxification from opioids, including taper...
Eligibility Criteria
Inclusion
- Availability to attend clinic 6 days a week for approximately 30-60 minutes per day.
- Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
- Participants must submit a urine sample negative for drugs of abuse other than opioids or marijuana prior to starting the study.
Exclusion
- Unstable medical condition or stable medical condition that would interact with study medications or participation.
- History of major psychiatric disorder (psychosis, schizophrenia, bipolar)
- Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
- Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or any drug that would have major interaction with drugs to be tested.
- Liver function tests greater than 3 times normal; BUN and Creatinine outside normal range.
- 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.
- Physical dependence on alcohol or drugs other than opioids, marijuana or tobacco (as determined by physician assessment).
- Pre-existing severe gastrointestinal narrowing.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01895270
Start Date
October 1 2013
End Date
April 1 2016
Last Update
June 5 2017
Active Locations (1)
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1
UAMS Psychiatric Research Institute
Little Rock, Arkansas, United States, 72205