Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
Study Details
Study Description
Brief 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. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
We hope to learn if Palonosetron and/or combination with hydroxyzine can be used to prevent or attenuate the signs and symptoms of opioid withdrawal. If we find that it can help prevent these symptoms, it may become a new treatment that can aid patients suffering from these symptoms.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Sequence 1: Placebo, Combo, Palonosetron At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Placebo Week 2: Palonosetron + Hydroxyzine Combo Week 3: Palonosetron |
Drug: Palonosetron
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Drug: Hydroxyzine
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Other: Placebo
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
|
Experimental: Sequence 2: Palonosetron, Combo, Placebo At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron Week 2: Palonosetron + Hydroxyzine Combo Week 3: Placebo |
Drug: Palonosetron
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Drug: Hydroxyzine
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Other: Placebo
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
|
Experimental: Sequence 3: Combo, Placebo, Palonosetron At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron + Hydroxyzine Combo Week 2: Placebo Week 3: Palonosetron |
Drug: Palonosetron
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Drug: Hydroxyzine
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Other: Placebo
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
|
Experimental: Sequence 4: Placebo, Palonosetron, Combo At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Placebo Week 2: Palonosetron only Week 3: Palonosetron + Hydroxyzine Combo |
Drug: Palonosetron
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Drug: Hydroxyzine
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Other: Placebo
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
|
Experimental: Sequence 5: Combo, Palonosetron, Placebo At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron + Hydroxyzine Combo Week 2: Palonosetron only Week 3: Placebo |
Drug: Palonosetron
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Drug: Hydroxyzine
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Other: Placebo
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
|
Experimental: Sequence 6: Palonosetron, Placebo, Combo At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron only Week 2: Placebo Week 3:Palonosetron + Hydroxyzine Combo |
Drug: Palonosetron
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Drug: Hydroxyzine
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
Other Names:
Other: Placebo
Over 3 study visits, patients will receive one of the following treatment regimens:
Placebo saline IV and sugar pill
0.75 mg Palonosetron IV and sugar pill
0.75 mg Palonosetron IV and 100 mg hydroxyzine PO
|
Outcome Measures
Primary Outcome Measures
- OOWS Score [Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)]
The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session. OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications. Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups
Secondary Outcome Measures
- SOWS Score [Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration)]
The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session. The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal. Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy males
-
Ages 18-35
-
No allergies to morphine or palonosetron
-
No history of addiction or substance abuse
Exclusion Criteria:
-
Female
-
Younger than 18 or older than 35
-
History of substance abuse
-
Raynaud's disease or coronary artery disease
-
Allergies to morphine or palonosetron
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Stanford University
Investigators
- Principal Investigator: Dr Larry Fu-nien Chu, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
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- SU-04152008-1099
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Sequence 1: Placebo, Combo, Palonosetron | Sequence 2: Palonosetron, Combo, Placebo | Sequence 3: Combo, Placebo, Palonosetron | Sequence 4: Placebo, Palonosetron, Combo | Sequence 5: Combo, Palonosetron, Placebo | Sequence 6: Palonosetron, Placebo, Combo |
---|---|---|---|---|---|---|
Arm/Group Description | At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Placebo Week 2: Combo Week 3: Palonosetron | At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron Week 2: Combo Week 3: Placebo | At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Combo Week 2: Placebo Week 3: Palonosetron | At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Placebo Week 2: Palonosetron Week 3: Combo | At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Combo Week 2: Palonosetron Week 3: Placebo | At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. Week 1: Palonosetron Week 2: Placebo Week 3: Combo |
Period Title: Overall Study | ||||||
STARTED | 2 | 2 | 2 | 1 | 2 | 1 |
COMPLETED | 2 | 2 | 2 | 1 | 2 | 1 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Over three study sessions each spaced one week apart participants received either placebo IV + PO, Palonosetron IV (0.75 mg) + placebo PO, or Palonosetron IV (0.75 mg) + Hydroxyzine PO (100mg). |
Overall Participants | 10 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
21.1
(2.18)
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
10
100%
|
Region of Enrollment (participants) [Number] | |
United States |
10
100%
|
Outcome Measures
Title | OOWS Score |
---|---|
Description | The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session. OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications. Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups |
Time Frame | Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Palonosetron | Palonosetron + Hydroxyzine |
---|---|---|---|
Arm/Group Description | Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal. | Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal. | Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal. |
Measure Participants | 10 | 10 | 10 |
Mean (Standard Error) [units on a scale (OOWS Scale)] |
3.5
(0.76)
|
1.0
(0.37)
|
0
(0.13)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Palonosetron, Palonosetron + Hydroxyzine |
---|---|---|
Comments | Null Hypothesis: There will be no difference in OOWS scores when comparing treatment groups (Palonosetron & Palonosetron + Hydroxyzine) with placebo. Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.0001 |
Comments | p-value represents comparison between OOWS scores at T=180 and the baseline measurements at T=-30. | |
Method | Friedman Test | |
Comments |
Title | SOWS Score |
---|---|
Description | The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session. The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal. Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine |
Time Frame | Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Placebo | Palonosetron | Palonosetron + Hydroxyzine |
---|---|---|---|
Arm/Group Description | Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal. | Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal. | Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal. |
Measure Participants | 10 | 10 | 10 |
Mean (Standard Error) [units on a scale (SOWS Scale)] |
6.0
(1.86)
|
4.0
(1.86)
|
3.5
(1.39)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Placebo, Palonosetron, Palonosetron + Hydroxyzine |
---|---|---|
Comments | Null Hypothesis: There will be no difference in SOWS scores when comparing the 2 treatment groups (Palonosetron & Palonosetron + Hydroxyzine) with placebo. Analysis of the data obtained in our prior study indicated that analysis of 10 individuals would provide 90% power to detect a treatment effect. Therefore, we examined the effect of three different pretreatments on naloxone-induced opiate withdrawal signs in 10 healthy individuals. | |
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.2244 |
Comments | p-value represents comparison between SOWS scores at T=180 and the baseline measurements at T=-30. | |
Method | Friedman Test | |
Comments |
Adverse Events
Time Frame | Data on adverse events was recorded throughout the duration of the study including study session #1 (week 1), study session #2 (week 2) and study session #3 (week 3). | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Placebo | Palonosetron + Placebo | Palonosetron + Hydroxyzine | |||
Arm/Group Description | At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with placebo (0.9% normal saline) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. | At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study drug combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. | At timepoint T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. Participants returned for three study sessions, each one week apart to receive all three study combinations. This was followed at T = 30 by intravenous morphine (10mg/70kg). At T = 165, 10mg/70kg naloxone IV was given to precipitate opioid withdrawal. The objective opioid withdrawal score (OOWS) and subjective opioid withdrawal score (SOWS) were determined 5 and 15 minutes after naloxone administration (T = 170, 180, respectively). Baseline measurements were recorded at T = -30 and T = -15. | |||
All Cause Mortality |
||||||
Placebo | Palonosetron + Placebo | Palonosetron + Hydroxyzine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Placebo | Palonosetron + Placebo | Palonosetron + Hydroxyzine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Placebo | Palonosetron + Placebo | Palonosetron + Hydroxyzine | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Larry Chu |
---|---|
Organization | Stanford University School of Medicine |
Phone | (650) 723-6632 |
lchu@stanford.edu |
- SU-04152008-1099