Trial Outcomes & Findings for Extended-release Naltrexone for Alcohol Dependence in Primary Care (NCT NCT00620750)

NCT ID: NCT00620750

Last Updated: 2011-09-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2011-09-27

Participant Flow

The study began July 2007. Community recruitment was performed from August 2007 to September 2008 in the primary care clinics of Bellevue Hospital and Gouverneur Diagnostic and Treatment Centers, two public hospital facilities in lower Manhattan. 116 persons contacted study staff regarding possible participation, and 76 were consented and screened.

Four consented patients were ineligible due to elevated liver function tests (n = 2), opioid dependence (n =1), and an uncontrolled psychiatric condition (n = 1). Seventy two participants met eligibility criteria and consented to study involvement, sixty-five participants presented for the initial treatment visit.

Participant milestones

Measure	Extended Release Injectable Naltrexone This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
Overall Study STARTED	65
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure

Extended Release Injectable Naltrexone This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.

Overall Study Lost to Follow-up

25

Baseline Characteristics

Extended-release Naltrexone for Alcohol Dependence in Primary Care

Baseline characteristics by cohort

Measure	Extended Release Injectable Naltrexone n=65 Participants This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	46 years STANDARD_DEVIATION 8.535196 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Per protocol

Outcome measures

Measure

Extended Release Injectable Naltrexone n=65 Participants This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.

Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections

40 Percent of participants

Adverse Events

Extended Release Injectable Naltrexone

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	Extended Release Injectable Naltrexone n=65 participants at risk This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
Injury, poisoning and procedural complications Severe injection site reaction	1.5% 1/65 • Number of events 1
Pregnancy, puerperium and perinatal conditions unexpected pregnancy	1.5% 1/65 • Number of events 1

Other adverse events

Measure	Extended Release Injectable Naltrexone n=65 participants at risk This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
Injury, poisoning and procedural complications any injection site reaction	46.2% 30/65 • Number of events 30
Gastrointestinal disorders nausea	27.7% 18/65 • Number of events 18
General disorders fatigue	12.3% 8/65 • Number of events 8
General disorders headache	9.2% 6/65 • Number of events 6
General disorders flu-like symptoms	9.2% 6/65 • Number of events 6
General disorders insomnia	9.2% 6/65 • Number of events 6
General disorders AST/ALT >5x normal	3.1% 2/65 • Number of events 2
General disorders other complaints	33.8% 22/65 • Number of events 22

Additional Information

Marc Gourevitch, MD, MPH

New York University School of Medicine

Phone: 212-263-8553

Email: marc.gourevitch@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place