Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/23/2018 |
| Start Date: | September 1, 2018 |
| End Date: | June 30, 2020 |
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.
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.
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.
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.
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).
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