Substance Withdrawal Syndrome
Conditions
Brief summary
We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.
Interventions
DRUGOndansetron and Placebo crossover
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Over 18 years of age * No medical contraindications to medication * Able to fulfill research procedures
Exclusion criteria
-Subjects who are unable to respond to our questionnaires or to stimuli as required by the experimental protocol will be excluded. * Subjects will be excluded if they have a history of significant psychiatric disorders that would prevent them from engaging in a treatment program. * Participating in other studies that would interfere with the procedures in this study * Known or apparent pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Withdrawal Symptoms With Placebo and With Ondansetron | Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of 31 patients enrolled, 17 did not experience withdrawal symptoms and were therefore not assigned an intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Placebo | Physician Decision | 4 |
| Placebo | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Placebo Then Ondansetron |
|---|---|
| Age, Continuous | 42.8 years |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Change in Withdrawal Symptoms With Placebo and With Ondansetron
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo - Sugar Pill | Change in Withdrawal Symptoms With Placebo and With Ondansetron | -22.08 Percent change | Standard Error 8.61 |
| Ondansetron | Change in Withdrawal Symptoms With Placebo and With Ondansetron | -42.71 Percent change | Standard Error 7.47 |