Evidence map›Paper›PMID 19058924›Full record

ReviewDrug and alcohol dependence2009

Ethical concerns about non-active conditions in smoking cessation trials and methods to decrease such concerns.

John R Hughes

Abstract readReview
In one paragraph

Review in Drug and alcohol dependence, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–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

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Efficacy of varenicline to prompt quit attempts in smokers not currently trying to quit: a randomized placebo-controlled trial.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2011
    Trial
  5. Article
  6. Review
  7. Article
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

1 author.

John R HughesUniversity of Vermont, Department of Psychiatry, UHC Campus, OH3 Stop # 482, Burlington, VT 05401, USA. john.hughes@uvm.edu

Funding

REDUCED SMOKING TO PROMPT SMOKING CESSATIONR01DA011557 · NIDA · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI HUGHES, JOHN R · 1998 to 2007
$2.7M
Research on Tobacco and Marijuana Cessation &ReductionK05DA000490 · NIDA · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI HUGHES, JOHN R · 2000 to 2009
$1.4M
Internal Barriers to Seeking Smoking Cessation TreatmentR01DA017825 · NIDA · UNIVERSITY OF VERMONT &ST AGRIC COLLEGE · PI HUGHES, JOHN R · 2005 to 2007
$1.2M
NIDA NIH HHS DA00490NIDA NIH HHS DA11557NIDA NIH HHS DA17825NIDA NIH HHS K05 DA000490
6 · The paper itself

Abstract

Many have questioned whether it is ethical to assign participants in a research trial to a non-active control condition (e.g., a placebo or attention-only control) when (a) the disorder under study is serious, (b) validated treatment is available, and (c) harm may occur if treatment is not given. This ethical concern may apply to studies of controlled trials of treatments for drug dependence. The current paper examines this concern for trials of nicotine dependence because there are multiple validated treatments available. The major harm from assignment to a non-active condition in such a trial could occur if failure to quit discourages smokers from trying to quit again. Whether this harm actually occurs is unclear. Potential harms from non-active conditions may be mitigated by (a) provision of more explicit information in the consent process, (b) inclusion of only those who have failed optimal treatment, (c) provision of validated treatment via a different modality, (d) tests of the new treatment as an add-on to standard treatment, (e) use of dose-response design, (f) use of unequal randomization designs, (g) use of stopping rules, (h) provision of optimal therapy to those who fail during the study, or (i) comparison of the experimental treatment vs. standard treatment. Empirical research to inform ethical analysis of non-active conditions in drug abuse research is suggested.

Indexed as

Clinical Trials as TopicControl GroupsEthical AnalysisHumansSmokingSmoking Cessation

Identifiers

PMID19058924
PMCPMC2656110

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.