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| ID | Type | Description | Link |
|---|---|---|---|
| 14228 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - sugar pill | Placebo Comparator | Placebo - sugar pill |
|
| Ondansetron | Experimental | Ondansetron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron and Placebo crossover | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron |
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Inclusion Criteria:-Over 18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Sean Mackey | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
Of 31 patients enrolled, 17 did not experience withdrawal symptoms and were therefore not assigned an intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo |
|
| |||||||||||||||||||||
| Ondansetron |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | Percent change | Baseline, 1 hour post dose Placebo, 1 hour post dose Ondansetron |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo - Sugar Pill | Placebo - sugar pill Ondansetron and Placebo crossover |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab | Stanford University | (650) 498-6477 | smackey@pain.stanford.edu |
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| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Ondansetron |
Ondansetron Ondansetron and Placebo crossover |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Ondansetron | Ondansetron Ondansetron and Placebo crossover | 0 | 14 | 0 | 14 |
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| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |