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Study Title and Description

Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety.



Key Questions Addressed
1 Evidence map
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Primary Publication Information
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TitleData
Title Reduction of alcohol drinking in young adults by naltrexone: a double-blind, placebo-controlled, randomized clinical trial of efficacy and safety.
Author O'Malley SS., Corbin WR., Leeman RF., DeMartini KS., Fucito LM., Ikomi J., Romano DM., Wu R., Toll BA., Sher KJ., Gueorguieva R., Kranzler HR.
Country Connecticut Mental Health Center, 34 Park St, New Haven, CT 06519 Stephanie.omalley@yale.edu.
Year 2015
Numbers Pubmed ID: 25742208

Secondary Publication Information
UI Title Author Country Year
Daily relations among affect, urge, targeted naltrexone, and alcohol use in young adults. Bold KW., Fucito LM., Corbin WR., DeMartini KS., Leeman RF., Kranzler HR., O'Malley SS. Department of Psychiatry. 2016
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Urgency traits moderate daily relations between affect and drinking to intoxication among young adults. Bold KW., Fucito LM., DeMartini KS., Leeman RF., Kranzler HR., Corbin WR., O'Malley SS. Yale School of Medicine, Department of Psychiatry, New Haven, CT, United States. Electronic address: krysten.bold@yale.edu. 2017
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Longitudinal findings from a randomized clinical trial of naltrexone for young adult heavy drinkers. DeMartini KS., Gueorguieva R., Leeman RF., Corbin WR., Fucito LM., Kranzler HR., O'Malley SS. Department of Psychiatry, Yale School of Medicine. 2016
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Drinking goals and attainment in a naltrexone trial of young adult heavy drinkers. DeMartini KS., Foster DW., Corbin WR., Fucito LM., Romano D., Leeman RF., Kranzler HR., O'Malley SS. Department of Psychiatry. 2018
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Extraction Form: Evidence Map
Arms
Number Title Description Comments
1 Naltrexone_MI
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2 Placebo_MI
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Design Details
Question... Follow Up Answer Follow-up Answer
Should this citation be included? Yes
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Does this paper originate from a primary study of interest? No
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No
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Ages eligible (in years) 18
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25
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Total sample size (in all arms) 140
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Age distribution of enrolled population (in years) 21.3
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Substance used Alcohol
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Interventions studied? Behavioral
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Combined behavioral and pharmacologic
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Outcome? Self report of use/abstinence and/or intensity
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Age variation of enrolled population (in years) 2.1
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Study type RCT
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Is any arm a brief intervention (or single session)? No
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Income level of country(ies) of origin Upper income
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Results & Comparisons


Results Data
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 9 9
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 8 5
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 4 2
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 22 16
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 14 11
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 4 7
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 4 6
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 0 0
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 11 6
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 7 9
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 5 7
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 31 23
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 12 14
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 8 7
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 10 2
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 18 14
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 4 7
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 18 22
Counts 4 4
Outcome: Adverse event      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


2 months

N Analyzed 61 67
Counts 2 6
Outcome: pct heavy drinking days      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


0 months

N Analyzed 61 67
Mean 34.3 33.4
SD 16.76 13.68
SE


2 months

N Analyzed 61 67
Mean 21.6 22.9
SD 16.05 13.20
SE
Outcome: alcohol use days      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


0 months

N Analyzed 61 67
Mean 43.3 49.5
SD 21.77 14.69
SE


2 months

N Analyzed 61 67
Mean 56.6 62.5
SD 22.52 15.75
SE
Outcome: drinks per drinking day      Population: All Participants
Time Point Measure Naltrexone_MI Placebo_MI


0 months

N Analyzed 61 67
Mean 6.7 6.8
SD 2.90 2.51
SE


2 months

N Analyzed 61 67
Mean 4.9 5.9
SD 2.28 2.51
SE
Mean Difference 95% CI low 95% CI high P-Value Mean Difference 95% CI low 95% CI high P-Value
Outcome: BYAACS      Population: All Participants Between-Arm Comparisons
Time Point Measure Naltrexone_MI Placebo_MI Comparison Measure Naltrexone_MI vs. Placebo_MI


0 months

N Analyzed 61 67 nr
Mean 12.5 12.5 nr
SD 4.79 5.13 nr
nr


2 months

N Analyzed 61 67 -0.92
Mean 4.7 5.6 -2.32
SD 3.59 3.9 0.47
0.19


Quality Dimensions
Dimension Value Notes Comments
Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation No
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Group similarity at baseline (selection bias): Selection bias due to dissimilarity at baseline for the most important prognostic indicators Yes
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Co-interventions (performance bias): Performance bias because co-interventions were different across groups Yes
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Compliance (performance bias): Performance bias due to inappropriate compliance with interventions across groups Yes
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Timing of outcome assessments (detection bias): Detection bias because important outcomes were not measured at the same time across groups Yes
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Additional Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes. No
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Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence Unclear
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Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment Low
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Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study Low
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Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study. Low
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Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors. Low
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Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data Low
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Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
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Quality Rating
No quality rating data was found.