Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal - Full Text View - ClinicalTrials.gov (2023)

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 Name: Aloxi


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 Name: Vistaril, Atarax


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 Name: Aloxi


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 Name: Vistaril, Atarax


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 Name: Aloxi


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 Name: Vistaril, Atarax


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 Name: Aloxi


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 Name: Vistaril, Atarax


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 Name: Aloxi


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 Name: Vistaril, Atarax


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 Name: Aloxi


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 Name: Vistaril, Atarax


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

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