Evidence map›Paper›PMID 27521807›Full record

Trial reportContemporary clinical trials2016

An exploratory evaluation of Take Control: A novel computer-delivered behavioral platform for placebo-controlled pharmacotherapy trials for alcohol use disorder.

Eric G Devine, Megan L Ryan, Daniel E Falk, Joanne B Fertig, Raye Z Litten

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Eric G DevineDepartment of Psychiatry, Boston University School of Medicine, Boston, MA, USA. Electronic address: eric.devine@bmc.org.
Megan L RyanNIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Daniel E FalkNIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Joanne B FertigNIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Raye Z LittenNIAAA's Clinical Investigations Group (NCIG), Division of Medications Development, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.

Funding

NICHD NIH HHS HHSN275200900005CNICHD NIH HHS HHSN275201400001C
6 · The paper itself

Abstract

Placebo-controlled pharmacotherapy trials for alcohol use disorder (AUD) require an active behavioral platform to avoid putting participants at risk for untreated AUD and to better assess the effectiveness of the medication. Therapist-delivered platforms (TDP) can be costly and present a risk to study design because of the variability in therapist fidelity. Take Control is a novel computer-delivered behavioral platform developed for use in pharmacotherapy trials sponsored by the National Institute on Alcohol Abuse and Alcoholism Clinical Investigations Group (NCIG). This behavioral platform was developed with the goal of reducing trial implementation costs and limiting potential bias introduced by therapists providing TDP. This exploratory study is the first to compare Take Control with TDP on measures related to placebo response rate, medication adherence, and participant retention. Data were drawn from the placebo arms of four multisite, double-blind, randomized controlled trials (RCT) for AUD conducted by NCIG from 2007 to 2015. Data were compared from subjects receiving TDP (n=156) in two RCTs and Take Control (n=155) in another two RCTs. Placebo response rate, as represented by weekly percentage of heavy drinking days, was similar between groups. Subjects who received Take Control had a higher rate of medication adherence than those who received TDP. Subject retention was not significantly different between groups. The findings suggest that Take Control is comparable to TDP on measures of retention, medication adherence, and placebo response. Additional research is needed to evaluate Take Control directly against TDPs in a randomized trial.

Indexed as

Drug MonitoringSoftwareAdultAlcohol-Related DisordersAntidiuretic Hormone Receptor AntagonistsBehavior TherapyCombined Modality TherapyDouble-Blind MethodFemaleHumansLevetiracetamMaleMiddle AgedPiracetamPlacebosQuetiapine FumarateAntidiuretic Hormone Receptor AntagonistsLevetiracetamPiracetamPlacebosQuetiapine FumarateVareniclineAlcohol use disorderBehavioral platformComputer-based interventionRandomized controlled trialTake control

Identifiers

PMID27521807
PMCPMC5065069

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.