Clinical trial NCT02785536: RITCH: Reducing Disparities in Tobacco Cessation Outcomes
Official title: RITCH: Reducing Disparities in Tobacco Cessation Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: minority health
social class
healthcare disparities
tobacco use disorder
Lead sponsor: The City College of New York
Sponsor class: OTHER
Collaborators: name: Virginia Tech Carilion School of Medicine and Research Institute
First posted: 2016-05-30
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US primarily due to an unequal burden of tobacco-related disease from a disproportionate share of smokers in African American and lower socioeconomic (SES) groups. Unlike many other health risk behaviors, tobacco-related health disparities are increasing despite a large treatment network of free telephone and in-person counseling services, perhaps due to significant disparities in treatment outcomes. The goal of this project is to revise the standard treatment for tobacco dependence to address key factors associated with treatment outcome disparities and more fully meet the needs of lower SES and African American smokers thereby reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting the alarming increase in tobacco-related health disparities, and reducing a leading cause of racial and socioeconomic health disparities in the US.

Detailed description: This study will be conducted in five phases. Each phase utilizes the results from the previous phase. Each phase is also associated with at least one specific aim.

Phase One (Aim One): Complete a revised version of a standard, widely utilized, multi-component, cognitive-behavior treatment manual for tobacco dependence to include commonly utilized, cognitive-behavioral interventions that specifically address the key factors associated with treatment outcome disparities.

Phase Two (Aim Two): Using the PEN-3 Model,1-3 target and tailor RITCh_1 to address the needs of smokers who are of lower SES as well as smokers who are minority, particularly African American. In this preparatory activity, the research team will tailor and target RITCh_1 using this well-accepted theoretical model and produce the second draft of the revised treatment, called RITCh_2. Human subjects are not involved with this phase of the research. No data will be collected.

Phase Three (Aim Three): Pilot test RITCh_2 with three treatment groups (5-10 participants per group) to assess understandability and acceptability and to ensure that it can be delivered in the same 60-minute per session time frame as the standard treatment. This is a qualitative study in which the investigators will pilot test RITCh_2 with 21 participants who will be consented as pilot study participants. See Pilot Study Informed Consent Form. Contact and demographic information will be collected from participants, but not baseline and outcome assessments. Participant feedback will be provided in a group format and will not be linked to identifying information. The research team will incorporate participant feedback into a third draft of the revised treatment, RITCh_3.

Phase Four (Aim Four): Compare the effects of SES on treatment outcomes in a socioeconomically and racially diverse group of participants treated with RITCh_3 and the standard treatment. The investigators will conduct a randomized controlled trial (n=253) comparing the efficacy of RITCh_3 to the standard treatment. Investigators will use a randomized treatment design and two methods for assessing abstinence (latency to relapse and six-month point prevalence abstinence rates) to compare the effects of SES and treatment condition on treatment outcomes. Investigators expect RITCh_3 to demonstrate fewer treatment outcome disparities than standard treatment.

Phase Five (Aim Five): Compare the effects of RITCH_3 and standard treatment on each of the key factors associated with treatment outcome disparities (see Aim One and Table 1). Using analysis of covariance and logistic regression as appropriate, investigators will analyze the effects of treatment condition on each of the key factors (see Table 1). The investigators expect participants treated with RITCh_3 to demonstrate more improvement on each of the key factors than participants treated with standard treatment.

Eligibility criteria: Inclusion Criteria:

* smoking cigarettes daily
* expressing a desire to quit smoking in the next 30 days
* no regular use of other tobacco products
* age 18 years or older
* no plans to move from the area in the next six months
* willing to comply with treatment
* able to engage in treatment

Exclusion Criteria:

* any contra-indication for use of the nicotine patch (i.e., uncontrolled high blood pressure, allergic reaction to patch adhesive, pregnancy, etc.),
* currently using mediations for smoking cessation (bupropion, varenicline, or any form of NRT)
* drinking more than 20 alcoholic drinks per week
* positive test on a urine screen for drugs of abuse at baseline (amphetamine, methamphetamine, cannabis, cocaine, opioids, methadone, etc.)
* current diagnosis that would prohibit engagement in brief CBT (active psychotic disorder, acute major depressive episode, significantly cognitively impaired)
* current regular use of other forms of tobacco other than smoking cigarettes

Primary outcomes:
measure: Latency to Relapse
timeFrame: 6 months following scheduled week 3 quit date
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The City College of New York
state: New York
Study officials:
affiliation: CCNY
name: Christine E Sheffer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lunden SE, Pittman JC, Prashad N, Malhotra R, Sheffer CE. Cognitive, Behavioral, and Situational Influences on Relapse to Smoking After Group Treatment for Tobacco Dependence. Front Psychol. 2019 Jan 30;9:2756. doi: 10.3389/fpsyg.2018.02756. eCollection 2018.