Are cannabis users who participate in a randomized clinical trial different from other treatment seekers?

Frewen, Amie; Baillie, Andrew; Montebello, Mark

doi:10.1016/j.jsat.2008.07.004

Cited by 6 publications

(8 citation statements)

References 23 publications

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“…This suggests that the trial sample was representative of the whole target population of self-reported smokers identified at maternity booking in NHS Greater Glasgow and Clyde (Table 1). This is similar to randomised controlled trial studies in cannabis dependence [25] and also in smoking and chewing tobacco cessation trials [26, 27] none of which were among pregnant women. However, other studies [28, 29] found their trial populations to be nonrepresentative in terms of demographic and clinical characteristics.…”

Section: Discussionsupporting

confidence: 83%

Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study

Bessing

Bauld

Sinclair

et al. 2016

Trials

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BackgroundThe limited representativeness of trial samples may restrict external validity. The aim of this study was to ascertain the representativeness of the population enrolled in the Cessation in Pregnancy Incentives Trial (CPIT), a therapeutic exploratory study to examine the effectiveness of financial incentives for smoking cessation during pregnancy.MethodsCPIT participants (n = 492) were compared with all self-reported smokers at maternity booking who did not participate in the trial (n = 1982). Both groups were drawn from the National Health Service (NHS) Greater Glasgow and Clyde area over a 1-year trial enrolment period. Variables used for comparison were age, area-based deprivation index, body mass index, gestation, and carbon monoxide (CO) breath test level. Chi-square and Mann-Whitney U tests were used to compare groups.ResultsFrom January to December 2012, 2474/13,945 (17.7 %) women, who booked for maternity care, self-reported as current smokers (at least one cigarette in the last week). Seven hundred and fifty-two were ineligible for trial participation because of a CO breath test level of less than 7 parts per million (ppm) used as a biochemical cut-off to corroborate self-report of current smoking. At telephone consent 301 could not be contacted, 11 had miscarried, 16 did not give consent and 3 opted out after randomisation, leaving 492 participants for analysis. There were no differences in demographic or clinical characteristics between trial participants, and self-reported smokers not enrolled in the trial in terms of CO breath test (as a measure of smoking level for those with a CO level of 7 ppm or higher), material deprivation (using an area-based measure), maternal age and maternal body mass index. Gestation at booking was statistically significantly lower for participants.ConclusionsTo ensure that all trial participants were smokers, biochemical validation excluded self-reported smokers with a CO level of less than 7 ppm from taking part in the trial, which excluded 30 % of self-reported smokers who were ‘lighter’ smokers. The efficacy of financial incentives would not have been likely to decrease if ‘lighter’ smokers had been included in the trial population. Trial participants were slightly earlier in their pregnancy at maternity booking, but this difference would not clinically affect the provision of financial incentives if provided routinely. Overall, the trial population was representative of all self-reported smokers with regard to available routinely collected data. Appropriate comparison of trial and target populations, with detailed reporting of exclusion criteria would contribute to the understanding of the wider applicability of trial results.Trial registrationCurrent Controlled Trials ISRCTN87508788. Registered/Assigned on 1 September 2011.

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Section: Discussionsupporting

confidence: 83%

Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study

Bessing

Bauld

Sinclair

et al. 2016

Trials

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“…However, the degree of Mj use did not prevent participation in randomized clinical trials among current Mj users. Specifically, Frewen and colleagues (2009) found that issues like severity of marijuana use, co-occurring mental health conditions and other medical issues did not serve as barriers to be enrolled, or take part in randomized trials. Furthermore, Cottler and colleague’s seminal study (1996) found little difference in retention by drug use.…”

Section: Introductionmentioning

confidence: 99%

Marijuana Use and Its Association with Participation, Navigation, and Enrollment in Health Research among African Americans

Webb

Striley

Cottler

2015

Journal of Ethnicity in Substance Abuse

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“…The search terms yielded one review of the prevalence of specific exclusion criteria in clinical trials of alcohol use disorder treatment , one review of ineligibility and refusal to participate in drug‐dependence treatment studies , one review which specifically examined the exclusion of individuals with alcohol use disorders from randomised clinical trials (RCT) of nicotine replacement therapies , two studies which used information in patient charts to judge whether patients seen in everyday practice would have been excluded from RCTs and 15 empirical examinations of the impact of study exclusion criteria on enrolment and/or results across treatment studies for different SUDs, comprising eight on alcohol , three on tobacco , two on cannabis , one on cocaine and one on multiple drugs . Several of these empirical studies took previously identified and operationalised exclusion criteria and applied them to unselected, generalisable populations to examine hypothetical exclusion rates.…”

Section: Resultsmentioning

confidence: 99%

Exclusion criteria in treatment research on alcohol, tobacco and illicit drug use disorders: A review and critical analysis

Moberg

Humphreys

2016

Drug and Alcohol Review

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Although some eligibility criteria are necessary to protect participant safety and ensure internal validity, researchers conducting studies on substance use disorder treatments should thoughtfully consider the justification for and specific operationalisation of the extensive exclusion criteria they often utilise. [Moberg C, Humphreys K. Exclusion criteria in treatment research on alcohol, tobacco and illicit drug use disorders: A review and critical analysis. Drug Alcohol Rev 2017;36:378-388].

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Are cannabis users who participate in a randomized clinical trial different from other treatment seekers?

Cited by 6 publications

References 23 publications

Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study

Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study

Marijuana Use and Its Association with Participation, Navigation, and Enrollment in Health Research among African Americans

Exclusion criteria in treatment research on alcohol, tobacco and illicit drug use disorders: A review and critical analysis

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