Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Long-acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone vs. Buprenorphine
Brief Summary: The investigators will randomize 210 opioid-dependent participants to one of two outpatient detoxification strategies: (1) a standard 7-day buprenorphine induction and gradual taper from 8 mg to 0 mg vs. (2) 7-day oral naltrexone induction; both groups will receive a single administration of a Vivitrol injection: at Day 8 for the naltrexone induction group and Day 15 for the buprenorphine group. The naltrexone arm is a modification of our current inpatient naltrexone induction procedure, consisting of a single day of buprenorphine followed by a washout day and 4 days of ascending oral naltrexone doses, prior to administering a dose of injectable naltrexone on Day 8. All participants will receive an intensive behavioral therapy for five weeks and will be followed for the subsequent 8 weeks to assess the longer-term outcome of the initial treatment. The primary outcome will be percentage of patients in each group successfully inducted onto Vivitrol. Key secondary outcomes will be 2-week abstinence at Weeks 4-5 (3rd and 4th weeks after Vivitrol injection), rates of completion of the 8-day detoxification, and percentage of patients in each group who return for additional Vivitrol injections in post-study follow-up. The main goal of this Stage 1a pilot study is to develop an improved outpatient opioid detoxification strategy, with particular relevance to newly diagnosed heroin addicts and prescription opioid abusers not seeking long-term agonist maintenance.

Specific Aim #1: To develop procedures for outpatient opioid detoxification which include naltrexone to facilitate detoxification.

Specific Aim #2: To compare injectable naltrexone induction rates between the naltrexone and buprenorphine groups following short-term outpatient opioid detoxification approach for initiating treatment for opioid dependence.


Options:
A: Arm Label: Sequence 1: Placebo, Combo, Palonosetron; Type: EXPERIMENTAL; Interventions: Drug: Palonosetron, Drug: Hydroxyzine, Other: Placebo | Arm Label: Sequence 2: Palonosetron, Combo, Placebo; Type: EXPERIMENTAL; Interventions: Drug: Palonosetron, Drug: Hydroxyzine, Other: Placebo | Arm Label: Sequence 3: Combo, Placebo, Palonosetron; Type: EXPERIMENTAL; Interventions: Drug: Palonosetron, Drug: Hydroxyzine, Other: Placebo | Arm Label: Sequence 4: Placebo, Palonosetron, Combo; Type: EXPERIMENTAL; Interventions: Drug: Palonosetron, Drug: Hydroxyzine, Other: Placebo | Arm Label: Sequence 5: Combo, Palonosetron, Placebo; Type: EXPERIMENTAL; Interventions: Drug: Palonosetron, Drug: Hydroxyzine, Other: Placebo | Arm Label: Sequence 6: Palonosetron, Placebo, Combo; Type: EXPERIMENTAL; Interventions: Drug: Palonosetron, Drug: Hydroxyzine, Other: Placebo | Intervention Type: DRUG; Name: Palonosetron; Assigned to Arm(s): 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 | Intervention Type: DRUG; Name: Hydroxyzine; Assigned to Arm(s): 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 | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): 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
B: Intervention Type: DRUG; Name: Buprenorphine/naloxone; Assigned to Arm(s): N/A
C: Arm Label: Group 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo comparator | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Naltrexone | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Naltrexone | Intervention Type: DRUG; Name: Naltrexone; Assigned to Arm(s): 2, 3 | Intervention Type: DRUG; Name: Placebo comparator; Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: naltrexone; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: naltrexone; Assigned to Arm(s): 3
D: Arm Label: Buprenorphine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Buprenorphine, Drug: Vivitrol | Arm Label: Oral naltrexone; Type: ACTIVE_COMPARATOR; Interventions: Drug: oral naltrexone, Drug: Buprenorphine, Drug: Vivitrol | Intervention Type: DRUG; Name: oral naltrexone; Assigned to Arm(s): Oral naltrexone | Intervention Type: DRUG; Name: Buprenorphine; Assigned to Arm(s): Buprenorphine, Oral naltrexone | Intervention Type: DRUG; Name: Vivitrol; Assigned to Arm(s): Buprenorphine, Oral naltrexone

Answer: D