Effect of Ondansetron for Withdrawal Symptoms

NCT ID: NCT00695864

Last Updated: 2017-05-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Withdrawal Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Placebo - sugar pill

Placebo - sugar pill

Group Type PLACEBO_COMPARATOR

Ondansetron and Placebo crossover

Intervention Type DRUG

Ondansetron

Ondansetron

Group Type EXPERIMENTAL

Ondansetron and Placebo crossover

Intervention Type DRUG

Interventions

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Ondansetron and Placebo crossover

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No medical contraindications to medication

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Sean Mackey

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Mackey

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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14228

Identifier Type: -

Identifier Source: secondary_id

SU-05222008-1180

Identifier Type: -

Identifier Source: org_study_id

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