Symptoms and General Pathology

All Conditions

Rare Diseases

Chronic Pain

Pain

Chronic Graft Versus Host Disease

Analgesics

Central Nervous System Depressants

Narcotic Antagonists

All Drugs and Chemicals

Buprenorphine

Analgesics, Opioid

Narcotics

Weekly visits with pharmacological and psychological support for opioid taper at 10% of original dose per week

Usual care for chronic pain. All care allowed except buprenorphine.

Weekly visits with physician's assistant (supervised by pain physician/psychiatrist and pain psychologist) who provides pharmacological and psychological support for opioid taper at 10% per week

opioid taper support

The proposed research will develop, demonstrate the feasibility of, and pilot test in a randomized controlled trial a prescription opioid taper support intervention. This intervention aims to prevent opioid misuse and adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain without evidence of current substance abuse.

The project will yield information essential to planning a future, larger-scale RCT designed to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse, misuse, overdose and other adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related activity interference, and mood. Participants in our pilot study will be limited to those without current opioid abuse or other substance abuse, but past substance abuse will be allowed. This will provide a sample of patients at risk for opioid abuse, misuse and overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid taper support intervention, as compared with patients randomized to usual opioid prescribing care, will have lower opioid average daily doses at 22 and 34 weeks.

Pilot Trial of Opioid Taper Support

Pilot Randomized Trial of Opioid Taper Support

mean daily opioid dose over past week as calculated in morphine equivalent dose

Prescription opioid difficulties subscale scores on: psychosocial problems and opioid control concerns

National Institute on Drug Abuse (NIDA)

University of Washington

Prinicipal Study Investigator

Substance Related Disorders

Behaviors and Mental Disorders

Syndrome

Substance Withdrawal Syndrome

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Antihypertensive Agents

Tin Fluorides

Lofexidine

Analgesics, Non-Narcotic

Clonidine

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Sympatholytics

Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.

Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.

Placebo

John Peppin, DO

Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.

This randomized, double-blind, placebo-controlled pilot study will evaluate the safety and effectiveness of LUCEMYRA in the treatment of opioid withdrawal during an opioid taper in subjects with chronic non-cancer pain.

Subjects will begin a planned 14-day complete taper of their pre-study opioid medications and will be randomly assigned (1:1) to either LUCEMYRA or matching placebo. Study drug will be administered through the opioid taper and for 5 days after the opioid taper is completed. Study drug will then be tapered over a 4-day period for a total of approximately 21 days exposure to study drug.

All subjects, study personnel (including the Investigator, study coordinator(s), pharmacist/designee), and the Sponsor will be blinded to the identity of the study drug (active or placebo) administered to subjects.

Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal

A Randomized, Double-Blind, Placebo-Controlled Pilot Study to Evaluate the Safety and Effectiveness of LUCEMYRA in the Treatment of Opioid Withdrawal During an Opioid Taper in Subjects With Chronic Non-Cancer Pain

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Trial of Opioid Taper Support	NCT01883882	Chronic Non-can...	opioid taper su...	18 Years - 80 Years	University of Washington
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal	NCT04070157	Opioid Withdraw...	Lofexidine Placebo	18 Years -	USWM, LLC (dba US WorldMeds)

Spots Global Cancer Trial Database for opioid taper

Every month we try and update this database with for opioid taper cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.