Improving Buprenorphine Detoxification Outcomes With Isradipine
Opioid Dependence
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, buprenorphine, isradipine, opioid withdrawal, opioid detoxification
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- UAMS Psychiatric Research Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Isradipine
Placebo
Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3-5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.
Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.