Clinical trial NCT03565497: Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation
Official title: Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Specific Aims for this Project Are:

1. To evaluate the ability of two forms of mindfulness training, relative to a control intervention, to engage specific "triple-vulnerability" mechanistic targets that characterize low SES smokers.

   1. The investigators hypothesize that both versions of the mindfulness training will show greater target engagement than the control treatment for mechanistic targets assessed under standard smoking conditions.
   2. The investigators hypothesize that the enhanced mindfulness training, Mindfulness+IE, will show greater target engagement than the other two conditions for mechanistic targets assessed during the nicotine deprivation window.
2. To show that the hypothesized differential target engagement results in differential smoking self-control as evaluated by greater time to lapse, fewer cigarettes smoked, and different smoking topography in the McKee Lapse protocol.
3. To expand and refine the list of SOBC targets by showing the specific relationship between currently identified assays and empirically-validated alternative targets, with attention to showing which of the targeted mechanisms in which contexts are most linked to clinically-relevant outcomes assessed in the McKee protocol, and which offer redundant or non-significant prediction.

Detailed description: This study is designed to evaluate the success of mechanistic target engagement in two specific contexts: under standard smoking conditions and under nicotine deprivation (stress) conditions. After screening, consent, and baseline assessment, participants selected on the basis of inclusion/exclusion criteria will be randomized to one of three intervention conditions: (1) a health-education control condition (CC), (2) a mindfulness training condition (MT), or (3) a mindfulness training condition combined with training applying mindfulness skills in the context of interoceptive exposure (Mindfulness+IE). Following 6 sessions of these interventions, delivered over 3 weeks, participants will then undergo the standard smoking assessment of mechanistic targets. Two days later (and matching the progression to quit-attempt challenges following treatment), participants will undergo the deprivation window assessment (14 hours of smoking abstinence) of these same mechanistic targets, followed by evaluation of lapse behavior and smoking topography in the McKee paradigm to yield: (1) latency to initiate smoking during a monetarily reinforced delay period, (2) the number of cigarettes smoked during a subsequent 60-minute self-administration period, and (3) exploratory analysis of smoking topography: puff volume, puff duration, and inter-puff interval. Participants will be recruited to Boston University through study advertisements targeted to low SES neighborhoods, with attention to health service centers and religious institutions serving low SES individuals.

Following telephone screening for basic eligibility, participants will be scheduled for an informed consent interview and subsequent baseline assessment session. Interventions are to be completed over the subsequent 3 weeks, and post-treatment assessments of the mechanistic targets are scheduled for one-week (standard smoking assessment) and one week + 2 days (deprivation-window assessment) from the last intervention session. For the standard smoking window assessments, participants are asked to smoke .5 hour before the scheduled assessment session. The deprivation-window assessment is scheduled two days later, (for example, scheduled for 12:00 noon, with smoking to cease at 10PM the night before). Upon arrival to the lab, nicotine abstinence will be verified by expired CO levels, as determined by a cut-off of half of the participant's screening session CO concentration or \<10 PPM (those failing will be rescheduled). After verification of abstinence, participants will complete assessment of the triple-risk mechanistic target variables. These assessments will be followed by the McKee Lapse protocol: participants will be instructed that over the next 50 min, they will have the option to initiate a cigarette self-administration (smoking) session at any point or to delay initiation in exchange for monetary reinforcement. If participants choose to delay, they will be awarded funds for each 5-minute increment they are able to resist smoking. Once participants choose to end the delay period in order to smoke (or resist smoking for the entire 50 minute delay period), they will then participate in a 60-minute cigarette self-administration session, in which they will be given the choice to either smoke their preferred brand of cigarettes or receive monetary reinforcement for cigarettes not smoked. Participants will be given funds at the beginning of the self-administration session and will lose a portion of the funds for each cigarette smoked. When participants smoke in this protocol, we will use the Clinical Research Support System (CReSS) to measure smoking topography. The reliability and acceptability of use of the portable CReSS device is well documented,88,94 and is recommended over direct observation. Topography data will include puff CO volume, puff duration, and inter-puff interval. Puff level data will be averaged to compute mean topography variables for each participant.

Eligibility criteria: Inclusion Criteria:

* be between 18 and 65 years of agehave reported household income of less than 1.5Xpoverty guidelines
* be a regular smoker for at least one year
* report daily smoking (minimum of 5 cigarettes per day and biochemically confirmed via Carbon Monoxide \[CO\] analysis; \> .10ppm CO)
* not be presently engaged in a quit attempt

Exclusion Criteria:

History of psychosis as determined by a brief psychotic screen, pregnancy, nursing mothers, medical conditions that would contraindicate smoking (e.g., current diagnoses of chronic medical diseases including heart disease, chronic obstructive pulmonary disease, or seizure disorders - assessed during telephone prescreen and initial assessment via medical checklist), nicotine use other than cigarette smoking, current use of any pharmacotherapy for smoking cessation, or insufficient command of the English language (i.e., cannot carry on a conversation with an interviewer in the English language or read associated text).

Primary outcomes:
measure: Negative Affect
timeFrame: 1-week Post-Intervention Smoking Context
measure: Negative Affect/Withdrawal
timeFrame: 1-week Post-Intervention Smoking Context
measure: N-Back Task
timeFrame: 1-week Post-Intervention Smoking Context
measure: Spatial Span
timeFrame: 1-week Post-Intervention Smoking Context
measure: Digit Span
timeFrame: 1-week Post-Intervention Smoking Context
measure: Anxiety Sensitivity
timeFrame: 1-week Post-Intervention Smoking Context
measure: Mirror-Tracing Persistence Task
timeFrame: 1-week Post-Intervention Smoking Context
measure: Negative Affect
timeFrame: 1week+2days Post-Intervention Deprivation Context
measure: Negative Affect/Withdrawal
timeFrame: 1week+2days Post-Intervention Deprivation Context
measure: N-Back Task
timeFrame: 1week+2days Post-Intervention Deprivation Contex
measure: Spatial Span
timeFrame: 1week+2days Post-Intervention Deprivation Contex
measure: Digit Span
timeFrame: 1week+2days Post-Intervention Deprivation Context
measure: Anxiety Sensitivity
timeFrame: 1week+2days Post-Intervention Deprivation Contex
measure: Mirror-Tracing Persistence Task
timeFrame: 1week+2days Post-Intervention Deprivation Context
Secondary outcomes:
measure: McKee Protocol Delay Until Smoking
timeFrame: 1week+2days Post-Intervention Deprivation Context
measure: McKee Protocol Number of Cigarettes Smoked
timeFrame: 1week+2days Post-Intervention Deprivation Context
measure: Smoking Topography-1
timeFrame: 1week+2days Post-Intervention Deprivation Context
measure: Smoking Topography-2
timeFrame: 1week+2days Post-Intervention Deprivation Context
measure: Smoking Topography-3
timeFrame: 1week+2days Post-Intervention Deprivation Context
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References:
citation: Otto MW, Zvolensky MJ, Rosenfield D, Hoyt DL, Witkiewitz K, McKee SA, Bickel WK, Smits JAJ. A randomized controlled trial protocol for engaging distress tolerance and working memory to aid smoking cessation in low socioeconomic status (SES) adults. Health Psychol. 2020 Sep;39(9):815-825. doi: 10.1037/hea0000858.