N/A
N=133
5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
Opioid Withdrawal · Physical Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01549652 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal) — 3.6; 3.6 units on a scale — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ondansetron (Drug); Placebo (Drug); Morphine (Drug); Naloxone 0.4 mg/70 kg (Drug); Naloxone 0.8 mg/70 kg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal) |
3.6; 3.6 | 0.87 |
| PRIMARY Change in Objective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence) |
4.5; 4.2 | 0.6 |
| SECONDARY Change in Subjective Opioid Withdrawal Score (SOWS) From Baseline (Prevention of Opioid Withdrawal) |
12.5; 12.2 | 0.92 |
| SECONDARY Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Opioid Withdrawal) |
-0.44 | 0.47 |
| SECONDARY Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Opioid Withdrawal) |
29.3; 28.3 | 0.91 |
| SECONDARY Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Opioid Withdrawal) |
-2.68 | <0.0001 sig |
| SECONDARY Change in Roland-Morris Disability Index (RMDI) From Baseline (Prevention of Opioid Withdrawal) |
-2.59 | 0.003 sig |
| SECONDARY Change in Subjective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence) |
16.4; 12.0 | 0.20 |
| SECONDARY Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Physical Dependence) |
-0.6; 0.2 | 0.34 |
| SECONDARY Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Physical Dependence) |
36.1; 29.2 | 0.40 |
| SECONDARY Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Physical Dependence) |
-2.9; -2.8 | 0.84 |
| SECONDARY Change in Roland-Morris Disability (RMDI) Index From Baseline (Prevention of Physical Dependence) |
-4.6; -2.0 | 0.02 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01549652). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.