Overview

This trial is active, not recruiting.

Conditions opioid withdrawal, physical dependence
Treatment ondansetron
Sponsor Stanford University
Collaborator National Institute on Drug Abuse (NIDA)
Start date April 2011
End date April 2015
Trial size 76 participants
Trial identifier NCT01549652, 1R01DA029078, 5HT3 19821

Summary

Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. This study aims to test the use of the drug ondansetron to reduce the symptoms associated with opioid withdrawal and to prevent the progression of opioid physical dependence, thereby allowing future investigators to better test the role of physical dependence in the development of addiction and also possibly improving acceptance of abstinence-based programs for addiction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ondansetron Zofran
Prevention of Physical Dependence: After 1 month of oral morphine therapy, patients will go to the Stanford human opioid physiology lab for opioid withdrawal testing for Visit #1. Patients will be randomized in a double-blind fashion to treatment crossover assignments (placebo vs. 32 mg ondansetron) that will be conducted on 2 separate visits at least 1 week apart. Patients will continue to take oral morphine therapy until both study visits are complete. Treatment of Opioid Withdrawal: Patients will be randomized into 2 groups: control arm (placebo) or prevention arm (8 mg ondansetron). Patients will go to the Stanford human opioid physiology lab for opioid withdrawal testing for Visit #1. After Visit #1, patients will undergo 1 month of oral morphine therapy. Patients will be instructed to take a treatment pill (placebo vs. ondansetron) with each dose of morphine. Then, patients will return to the Stanford human opioid physiology lab for Visit #2, which will be identical to Visit #1.
(Experimental)
ondansetron Zofran
Prevention of Physical Dependence: After 1 month of oral morphine therapy, patients will go to the Stanford human opioid physiology lab for opioid withdrawal testing for Visit #1. Patients will be randomized in a double-blind fashion to treatment crossover assignments (placebo vs. 32 mg ondansetron) that will be conducted on 2 separate visits at least 1 week apart. Patients will continue to take oral morphine therapy until both study visits are complete. Treatment of Opioid Withdrawal: Patients will be randomized into 2 groups: control arm (placebo) or prevention arm (8 mg ondansetron). Patients will go to the Stanford human opioid physiology lab for opioid withdrawal testing for Visit #1. After Visit #1, patients will undergo 1 month of oral morphine therapy. Patients will be instructed to take a treatment pill (placebo vs. ondansetron) with each dose of morphine. Then, patients will return to the Stanford human opioid physiology lab for Visit #2, which will be identical to Visit #1.

Primary Outcomes

Measure
Change in baseline of Objective Opioid Withdrawal Score
time frame: Changes in baseline OOWS scores will be measured on 3 study days, over the span of 1.5 months. The baseline OOWs score is measured at T=-10 min., after Ondasetron/Placebo infusion at T=15 min., and after the Naloxone infusion at T=35 and T=45 min.

Secondary Outcomes

Measure
Change in the Baseline of Subjective Opioid Withdrawal Score
time frame: Changes in baseline SOWS scores will be measured on 3 study days, over the span of 1.5 months. The baseline SOWs score is measured at T=-10 min., after Ondasetron/Placebo infusion at T=15 min., and after the Naloxone infusion at T=35 and T=45 min.
Beck Depression Inventory
time frame: Beck Depression Inventory is measured once at the start of each study visit, over the span of 1.5 months.
Pain Inventory
time frame: Pain inventory is measured once at the start of each study visit, over the span of 1.5 months.
Change in Baseline of Physical Vital Signs
time frame: Changes in baseline of physical vital signs is measured over the span of 1.5 months on 3 study days. Baseline physical vital signs are measured at T=-10, after Ondasetron/Placebo infusion at T=15, and after the Naloxone infusion at T=35 and T=45.
Serum Factors
time frame: Serum factors are measured at the end of every study visit, over the span of 1.5 months.
Pain Sensitivity
time frame: Changes in baseline of pain sensitivity are measured over the span of 1.5 months on 3 study days. Baseline pain sensitivity is measured at T=-10, after the Ondasetron/Placebo infusion at T=15, and after the Naloxone infusion at T=35 and T=45

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Diagnosis of chronic low-back pain and who may be taking up to 30 mg equivalent of morphine per day (such as Vicodin, Percocet, etc) - 18-60 years old - Eligible to escalate opioid therapy dose, as determined by the treating physician or PI - At low risk for addiction as determined by the PI and an addiction expert, Dr. Ian Carroll. Exclusion Criteria: - History of cardiovascular disease - History of peripheral neuropathic pain, scleroderma, or other condition that would preclude cold water forearm immersion - History of addiction or chronic pain conditions other than low-back pain, d) history of cardiac arrhythmia - History of hepatic disease - Use of steroid or nerve-stimulating medications - Any condition precluding opioid use - Pregnancy

Additional Information

Official title 5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
Principal investigator Larry F Chu, MD, MS
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Stanford University.