Trial Outcomes & Findings for Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal (NCT NCT00661674)
NCT ID: NCT00661674
Last Updated: 2017-06-05
Results Overview
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
COMPLETED
NA
10 participants
Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration)
2017-06-05
Participant Flow
Participant milestones
| Measure |
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: Combo
Week 3: Palonosetron
|
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: Combo
Week 3: Placebo
|
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: Combo
Week 2: Placebo
Week 3: Palonosetron
|
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
Week 3: Combo
|
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: Combo
Week 2: Palonosetron
Week 3: Placebo
|
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
Week 2: Placebo
Week 3: Combo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
1
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
Baseline characteristics by cohort
| Measure |
Overall Study
n=10 Participants
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).
|
|---|---|
|
Age, Continuous
|
21.1 years
STANDARD_DEVIATION 2.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo
n=10 Participants
Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
|
Palonosetron
n=10 Participants
Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
|
Palonosetron + Hydroxyzine
n=10 Participants
Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
|
|---|---|---|---|
|
OOWS Score
|
3.5 units on a scale (OOWS Scale)
Standard Error 0.76
|
1.0 units on a scale (OOWS Scale)
Standard Error 0.37
|
0 units on a scale (OOWS Scale)
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo
n=10 Participants
Each participant had one session in which they received a placebo tablet pretreatment prior to naloxone-precipitated withdrawal.
|
Palonosetron
n=10 Participants
Each participant had one session in which they received palonosetron IV pretreatment prior to naloxone-precipitated withdrawal.
|
Palonosetron + Hydroxyzine
n=10 Participants
Each participant had one session in which they received IV palonosetron + PO hydroxyzine pretreatment prior to naloxone-precipitated withdrawal.
|
|---|---|---|---|
|
SOWS Score
|
6.0 units on a scale (SOWS Scale)
Standard Error 1.86
|
4.0 units on a scale (SOWS Scale)
Standard Error 1.86
|
3.5 units on a scale (SOWS Scale)
Standard Error 1.39
|
Adverse Events
Placebo
Palonosetron + Placebo
Palonosetron + Hydroxyzine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place