Evidence map›Paper›PMID 24928218›Full record

Trial reportAddiction science & clinical practice2014

Rationale and design of a randomized controlled trial of varenicline directly observed therapy delivered in methadone clinics.

Shadi Nahvi, Kate S Segal, Alain H Litwin, Julia H Arnsten

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Addiction science & clinical practice, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01378858 (Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 27% 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.

NCT01378858 nacompletednot on this map

Varenicline Smoking Cessation Treatment for Methadone Maintenance Patients

TypeinterventionalSponsorAlbert Einstein College of MedicineRan2011 to 2015Enrolled100ConditionsTobacco Use Disorder, Medication AdherenceArmsVarenicline
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 8 citations in OpenAlex.

  1. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Nicotine receptor partial agonists for smoking cessation.The Cochrane database of systematic reviews · 2016
    Pooled it
  3. Trial
  4. Review
  5. Article
  6. Are Pharmacotherapies Ineffective in Opioid-Dependent Smokers? Reflections on the Scientific Literature and Future Directions.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2015
    Review
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

4 authors at 2 institutions in 1 country.

Shadi NahviDepartment of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, 111 East 210th Street, 10467 Bronx, NY, USA. snahvi@montefiore.org.
Kate S Segal
Alain H Litwin
Julia H Arnsten
Albert Einstein College of Medicine · USMontefiore Medical Center · US

Funding

Core-010UL1TR001073 · NCATS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI KELLER, MARLA J, SHAMOON, HARRY · 2013 to 2017
$21.3M
Varenicline Smoking Cessation Treatment for Methadone Maintenance PatientsK23DA025736 · NIDA · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI NAHVI, SHADI · 2010 to 2014
$903k
NCATS NIH HHS UL1 TR001073NIDA NIH HHS K23 DA025736
6 · The paper itself

Abstract

backgroundTobacco cessation medication adherence is one of the few factors shown to improve smoking cessation rates among methadone-maintained smokers, but interventions to improve adherence to smoking cessation medications have not yet been tested among methadone treatment patients. Methadone clinic-based, directly observed therapy (DOT) programs for HIV and tuberculosis improve adherence and clinical outcomes, but have not been evaluated for smoking cessation. We describe a randomized controlled trial to evaluate whether a methadone clinic-based, directly observed varenicline therapy program increases adherence and tobacco abstinence among opioid-dependent drug users receiving methadone treatment. METHODS/

designWe plan to enroll 100 methadone-maintained smokers and randomize them to directly observed varenicline dispensed with daily methadone doses or treatment as usual (self-administered varenicline) for 12 weeks. Our outcome measures are: 1) pill count adherence and 2) carbon monoxide-verified tobacco abstinence. We will assess differences in adherence and abstinence between the two treatment arms using repeated measures models. DISCUSSION: This trial will allow for rigorous evaluation of the efficacy of methadone clinic-based, directly observed varenicline for improving adherence and smoking cessation outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs and can guide protocols for studies among opioid-dependent smokers receiving methadone treatment.

trial registrationclinicaltrials.gov NCT01378858.

Indexed as

Directly Observed TherapySubstance Abuse Treatment CentersAdultBenzazepinesCross-Sectional StudiesFemaleFollow-Up StudiesHumansMaleMethadoneNew York CityOpioid-Related DisordersPilot ProjectsQuinoxalinesResearch DesignSelf AdministrationBenzazepinesMethadoneQuinoxalinesVarenicline

Identifiers

PMID24928218
PMCPMC4084498
OpenAlexW2142380778

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.