Naltrexone Injection for Alcoholism
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Pennsylvania
Must not be taking: Psychotropics, Anticonvulsants, Opioids, Anticoagulants
Disqualifiers: Planned surgery, Physical disease, Psychotic disorder, Drug use disorder, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This study is a phase IV, two-arm, randomized, double-blind, placebo-controlled study to assess whether individuals identified as primarily reward drinkers are significantly more likely to reduce heavy drinking if they receive XR-NTX than a matching placebo injection. Study subjects will receive monthly injections of long-acting injectable naltrexone 380 mg (4 mL) or matching placebo. All subjects will also receive 4 sessions of Medical Management (MM). Post-treatment follow-up visits will be conducted at 4 weeks after the scheduled completion of treatment.
Will I have to stop taking my current medications?
Yes, if you are currently taking psychotropic, anticonvulsant, opioid, anticoagulant, or alcohol use disorder treatment medications, you will need to stop them to participate in this trial.
What data supports the effectiveness of the drug Naltrexone Injection for Alcoholism?
How is the drug XR-NTX 380 mg unique for treating alcoholism?
XR-NTX 380 mg is unique because it is a once-a-month injection that helps reduce alcohol consumption and prolong abstinence in people with alcohol dependence, especially those who can abstain for a few days before starting treatment. This extended-release formulation provides a consistent effect over time, unlike daily oral medications.23456
Eligibility Criteria
Adults aged 18-65 with Alcohol Use Disorder (AUD) who drink heavily and want to cut down or stop. They must be able to understand the study, have a stable address, and use reliable birth control if applicable. Excluded are those with certain mental health conditions, on conflicting medications, facing potential incarceration soon, having significant physical diseases or abnormal lab results, drug disorders other than alcohol/nicotine/cannabis, needing detoxification from alcohol or with a history of bad reactions to XR-NTX.Inclusion Criteria
Current DSM-5 diagnosis of AUD
I am between 18 and 65 years old.
Primarily a reward drinker [i.e., with a score of >22 on the reward subscale and a score of <14 on the relief subscale of the Inventory of Drinking Situations (IDS)]
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Exclusion Criteria
I don't have any major health issues that could make joining the study unsafe for me.
Current psychotic disorder (bipolar, schizophrenia, major depression with suicidal ideation, or psychotic features) identified by clinical examination or the structured interview that could interfere with study participation or make it hazardous for the subject
History of allergy or other serious adverse event due to treatment with XR-NTX
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 day
1 visit (in-person or virtual)
Treatment
Participants receive monthly injections of XR-NTX or placebo and complete daily IVR calls
8 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Treatment Details
Interventions
- Medical Management (Behavioral)
- Placebo intramuscular injection (Drug)
- XR-NTX 380 mg, intramuscular injection (Opioid Antagonist)
Trial OverviewThe trial is testing whether long-acting injectable naltrexone (XR-NTX) helps people who primarily drink for pleasure more than a placebo in reducing heavy drinking. Participants will receive either XR-NTX or placebo injections monthly along with four sessions of Medical Management counseling over eight weeks.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: XR-NTX 380 mg, intramuscular injectionActive Control2 Interventions
Subjects will receive an injection of XR-NTX 380 mg (4 mL) repeated once after 4 weeks.
Group II: Inactive placebo intramuscular injectionPlacebo Group2 Interventions
Subjects will receive a placebo injection repeated once after 4 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Pennsylvania Center for Studies of AddictionPhiladelphia, PA
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Who Is Running the Clinical Trial?
University of PennsylvaniaLead Sponsor
Alkermes, Inc.Industry Sponsor
References
Treating Opioid Dependence With Injectable Extended-Release Naltrexone (XR-NTX): Who Will Respond? [2022]Once-monthly intramuscular extended-release naltrexone (XR-NTX) has demonstrated efficacy for the prevention of relapse in opioid dependence, providing an alternative to agonist or partial agonist maintenance (ie, methadone and buprenorphine). The question remains, for whom is this unique treatment most efficacious and can patient-treatment matching factors be identified?
Impact of treatment with intramuscular, injectable, extended-release naltrexone on counseling and support group participation in patients with alcohol dependence. [2011]: The impact of intramuscular, injectable, extended-release naltrexone (XR-NTX; Vivitrol) on counseling and support group participation was examined in a post hoc analysis of a 24-week, randomized, double-blind study in 624 alcohol-dependent adults, most of whom were nonabstinent at baseline.
Do patient characteristics moderate the effect of extended-release naltrexone (XR-NTX) for opioid use disorder? [2019]Extended release naltrexone (XR-NTX) injected intramuscularly monthly has been shown to reduce relapse in persons with opioid use disorder. Baseline factors, including patients' demographics, comorbidities and lifestyle, may help identify patients who will benefit most or least from XR-NTX treatment.
Population pharmacokinetics of extended-release injectable naltrexone (XR-NTX) in patients with alcohol dependence. [2019]Injectable extended-release naltrexone (XR-NTX; Vivitrol) has recently been approved for the treatment of alcohol dependence. A population pharmacokinetic (PPK) analysis examined the possibility of altered pharmacokinetics for naltrexone and its primary metabolite, 6beta-naltrexol, in subpopulations with a potential for alcohol-dependence treatment.
Effect of extended-release naltrexone (XR-NTX) on quality of life in alcohol-dependent patients. [2021]Extended-release naltrexone (XR-NTX) is a once-a-month injectable formulation for the treatment of alcohol dependence previously shown to reduce drinking and heavy drinking relative to placebo (Garbutt et al., 2005). A 24-week, randomized, double-blind, placebo-controlled study established the efficacy and safety of XR-NTX in this patient population. In this report, the effect of XR-NTX on quality of life (QOL) was examined.
Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. [2013]Extended-release naltrexone (XR-NTX) is a once-a-month injectable formulation that is Food and Drug Administration-approved for the treatment of alcohol dependence in patients able to abstain from alcohol before treatment initiation. This paper presents the results of an analysis of efficacy data from a subgroup of patients with 4 days or more of voluntary abstinence before treatment initiation (n = 82) on a wide range of drinking-related outcomes. In these patients, all of whom received counseling, the rate of abstinence was severalfold higher for XR-NTX 380 mg compared with placebo: median time to first drink was 41 days versus 12 days, respectively; rate of continuous abstinence at end of the study was 32% versus 11% (P = 0.02). Extended-release naltrexone 380 mg, compared with placebo, substantially increased time to first heavy drinking event (>180 days vs 20 days; P = 0.04) and decreased the median number of any drinking days per month by 90% (0.7 vs 7.2; P = 0.005) and heavy drinking days per month by 93% (0.2 days vs 2.9 days; P = 0.007). The XR-NTX 380 mg group also had more than twice as many responders compared with placebo (70% vs 30%; P = 0.006; responder defined as having no more than 2 heavy drinking days in any consecutive 28-day period) and experienced greater improvement in gamma-glutamyl transpeptidase levels (P = 0.03). Outcomes for XR-NTX 190 mg (n = 26) were generally intermediate, demonstrating a dose-response effect. In conclusion, XR-NTX 380 mg prolonged abstinence and reduced the number of heavy drinking days and drinking days in patients who were abstinent for as few as 4 days before treatment initiation.