Evidence map›Paper›PMID 33140994›Full record

Trial reportCurrent medical research and opinion2021

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder.

Yuri A Maricich, Warren K Bickel, Lisa A Marsch, Kirstin Gatchalian, Jeffrey Botbyl, Hilary F Luderer

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Current medical research and opinion, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00929253 (Efficacy of Computer Delivered CRA), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 4% of its field
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.

NCT00929253 nacompletednot on this map

Efficacy of Computer Delivered CRA (Bup II) Grant No. R01DA012997-10

TypeinterventionalSponsorVirginia Polytechnic Institute and State UniversityRan2007 to 2010Enrolled170ConditionsOpiate AddictionArmsSuboxone, CRA, Therapy, CM
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  15. Informing evidence-based medicine for opioid use disorder using pharmacoeconomic studies.Expert review of pharmacoeconomics & outcomes research · 2024
    Review
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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

6 authors at 3 institutions in 1 country.

Yuri A MaricichPear Therapeutics, Inc., Boston, MA, USA.
Warren K BickelFralin Biomedical Research Institute at VTC, Roanoke, VA, USA.
Lisa A MarschCenter for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH, USA.
Kirstin GatchalianFralin Biomedical Research Institute at VTC, Roanoke, VA, USA.
Jeffrey BotbylProvonix, Sewell, NJ, USA.
Hilary F LudererPear Therapeutics, Inc., Boston, MA, USA.
Biomedical Research Institute · USPear Therapeutics (United States) · USDartmouth College · US

Funding

Treatment Development & Evaluation CoreP30DA029926 · NIDA · DARTMOUTH COLLEGE · PI Lisa A. Marsch · 2011 to 2026
$21.5M
IMPROVING COMBINED BUPRENORPHINE-BEHAVIORAL TREATMENTR01DA012997 · NIDA · UNIV OF ARKANSAS FOR MED SCIS · PI BICKEL, WARREN K · 2000 to 2009
$8.9M
NIDA NIH HHS P30 DA029926NIDA NIH HHS R01 DA012997
6 · The paper itself

Abstract

objectivesTo evaluate the safety and efficacy of a digital therapeutic in treatment-seeking individuals with opioid use disorder (OUD) in an analysis of randomized clinical trial (RCT) data (ClinicalTrials.gov identifier: NCT00929253).

methodsSecondary analysis of an RCT including 170 adults meeting DSM-IV criteria for OUD. Participants were randomized to 12-weeks of treatment-as-usual (TAU) or TAU plus a digital therapeutic providing 67 digital, interactive educational modules based on the Community Reinforcement Approach. TAU consisted of buprenorphine maintenance therapy, 30 min biweekly clinician interaction, and abstinence-based contingency management. Primary endpoints were treatment retention and abstinence (negative urine drug screen) during weeks 9-12 of treatment. Safety was assessed by evaluating adverse events.

resultsParticipants randomized to TAU plus a digital therapeutic had significantly greater odds of opioid abstinence during weeks 9-12 compared to TAU: 77.3 versus 62.1%, respectively (

conclusionsA prescription digital therapeutic (PDT) in combination with buprenorphine therapy improves clinically significant patient outcomes including abstinence from illicit opioids and retention in treatment compared with treatment as usual.

Indexed as

PrescriptionsSafetyAdultBuprenorphineDrug Administration ScheduleHumansMaleOpioid-Related DisordersBuprenorphineCommunity reinforcement approachdigital therapeuticPDTprescription digital therapeuticreSET-Oretentionsubstance use disorderSUDTEStherapeutic education system

Identifiers

PMID33140994
PMCPMC8666102
OpenAlexW3096023668

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.