Trial Outcomes & Findings for Effect of Ondansetron for Withdrawal Symptoms (NCT NCT00695864)

Results Overview

Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron

Results posted on

2017-05-15

Participant Flow

Of 31 patients enrolled, 17 did not experience withdrawal symptoms and were therefore not assigned an intervention.

Participant milestones

Participant milestones
Measure	Placebo Then Ondansetron Dosage and form: Placebo - tablet Odansetron - 8 mg oral tablet Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron.
Placebo STARTED	14
Placebo COMPLETED	9
Placebo NOT COMPLETED	5
Ondansetron STARTED	14
Ondansetron COMPLETED	9
Ondansetron NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Then Ondansetron Dosage and form: Placebo - tablet Odansetron - 8 mg oral tablet Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron.
Placebo Withdrawal by Subject	1
Placebo Physician Decision	4

Baseline Characteristics

Effect of Ondansetron for Withdrawal Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Ondansetron n=14 Participants Dosage and form: Placebo - tablet Odansetron - 8 mg oral tablet Double-blind, placebo-controlled, cross-over trial. All participants received placebo first, followed by Ondansetron.
Age, Continuous	42.8 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron

Population: 9 participants and 13 independent trials (3 patients had more than 1 distinct withdrawal episode) were analyzed. Of the 14 participants assigned to intervention, 5 were withdrawn from the study and/or analysis.

Subjective Opioid Withdrawal Scale: Participants were asked to rate, from 0 to 4, their experience of 15 withdrawal symptoms. Scores for each participant were derived from the sum of their withdrawal symptoms score (minimum:0, maximum: 60). A higher score indicates more symptoms experienced and/or at a greater degree of severity.

Outcome measures

Outcome measures
Measure	Placebo - Sugar Pill n=9 Participants Placebo - sugar pill Ondansetron and Placebo crossover	Ondansetron n=9 Participants Ondansetron Ondansetron and Placebo crossover
Change in Withdrawal Symptoms With Placebo and With Ondansetron	-22.08 Percent change Standard Error 8.61	-42.71 Percent change Standard Error 7.47

Adverse Events

Placebo - Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ondansetron

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab

Stanford University

Phone: (650) 498-6477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place