SmokersPhase 4physioNCT01362101
Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
A Phase 4 study testing Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) in people with Smokers, run by A. Eden Evins at 1 site in United States.
Trial summary
This study is ancillary. Participants will be recruited as part of a separate clinical trial on effects of two intensive behavioral training programs that evaluates feasibility and efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to traditional behavioral therapy (CBT) for… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smokers
- What is being tested?
- Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria for the entire trial:
- Women and men aged 18-65, inclusive, who are competent, wish to participate and willing to provide informed consent.
- Self report smoking >=15 cigarettes/day.
- Expired air CO > 9ppm at the time of enrollment.
- Must be willing to participate in a meditation training group.
- Inclusion criteria for the physiological assessment:
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- Abstinent for at least 12 hrs prior to the assessment.
- CO<15ppm
- Have negative urine toxicology for illicit drugs or alcohol.
Who cannot join
- DSM-IV diagnosis of dementia, neurodegenerative disease, or other organic mental disorder, lifetime history of psychotic disorder, bipolar disorder, severe PTSD, Dissociative Identity Disorder, OCD, anorexia nervosa, mental retardation, or autism.
- History of moderate or severe major depressive episode or generalized anxiety disorder within the last 6 months.
- Use of prescribed psychotropic medication other than SSRI/NDRI/SNRI/ buprenorphine in past 6mo, or change in such psychiatric medication dose in past six months.
- History of active substance use disorder other than nicotine or caffeine in the last 6 months.
- Positive urine toxicology for illicit drugs, alcohol, opiates or benzodiazepines.
- Serious unstable medical illness including, cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 4 months. History of life-threatening arrhythmia, CHF, syncope, or myocardial infarction within the last year. Abnormal cardiovascular event, or uncontrolled hypertension within last 2 months.
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- History of cerebro-vascular events (i.e., stroke, TIA), multiple head injuries with neurological sequelae, a single severe head injury with lasting neurological sequelae, history of seizure disorder or current CNS tumor.
- Use of investigational medication in the past 30 days.
- Inability to speak, read, or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center For Addiction Medicine-Massachusetts General Hospital
Boston, Massachusetts, 02478
About this study
This study is ancillary. Participants will be recruited as part of a separate clinical trial on effects of two intensive behavioral training programs that evaluates feasibility and efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to compare the effect of MT to that of traditional CBT on a physiological marker of stress, salivary cortisol concentration, and physiological responses to smoking cues in tobacco smokers. The investigators will use electrophysiological reactivity to smoking cues in the form of audio recordings of personalized scripts describing the scenarios associated with the strongest urges to smoke that will provide a physiological validation to a behavioral intervention. The investigators will also explore correlations between these biological markers and self report of stress, craving and negative affect to supplement self report and behavioral outcome measures with biological and physiological markers to represent improvement attributed to the intervention.
- Conditions
- Smokers
- Being tested
- Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)
- Keywords
- cue reactivity, physiologic activation, craving, smoking cues, Behavioral therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)Behavioural
60 smokers will enter a separate 4 wk group sessions trial that evaluates efficacy of MT in comparison to CBT for smoking cessation. During the parent study, participants will receive bi-weekly sessions of either MT or CBT, for 4 weeks and to set a quit date at the end of the 2nd week. In this context, we will examine participants at two points:
- Week 0-1 of MT/CBT: development of smoking scripts based participant's descriptions of situations that trigger tobacco craving.
- Then participants will undergo pre-treatment (week 0-1) and post treatment (week 4) psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues, salivary cortisol testing and to complete a computerized SST protocol.
| Study group | Role | What they receive |
|---|---|---|
| Traditional behavioral intervention | Active comparator | Not described Receives: Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) |
| Mindfulness behavioral intervention | Active comparator | Not described Receives: Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiologic reactivity (skin conductance, Heart rate, electromyogram, cortisol measures) to smoking cues in recently abstinent tobacco smokers
- Wk 0: development of scripts based on participant's descriptions of the most salient aspects of the smoking experience that triggers craving. Then they will undergo pre-treatment psychophysiological activation to smoking-related cues using the script driven imagery technique (smoking-related and affectively neutral scripts), in vivo cues and salivary cortisol testing.
- Wk 4: After the last MT or CBT session, participants will undergo post-treatment psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues and salivary cortisol testing.
Measured: It will be measured twice during the study: before treatment (baseline at week 0) and an average of 7 days after treatment (end point assessment)
Secondary outcomes (1)
self reported of cue-induced negative affect, craving, and stress in recently abstinent tobacco smokers
Measured: It will be measured twice at the baseline assessment (before and after script driven imagery) and twice at the end point assessment (before and after script driven imagery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startJul 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Eden Evins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, A. Eden Evins, Massachusetts General Hospital
- Investigators
- Gladys N Pachas, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01362101
- Sponsor's protocol ID
- 2010P-001316
- Acronym
- physio
- Status last verified
- Jul 2013
- First submitted
- 23 May 2011
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
- ClinicalTrials.gov ID
- NCT01362101
- Acronym / sponsor ID
- physio / 2010P-001316
- Conditions
- Smokers
- Keywords
- cue reactivity, physiologic activation, craving, smoking cues, Behavioral therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- A. Eden EvinsUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is ancillary. Participants will be recruited as part of a separate clinical trial on effects of two intensive behavioral training programs that evaluates feasibility and efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to compare the effect of MT to that of traditional CBT on a physiological marker of stress, salivary cortisol concentration, and physiological responses to smoking cues in tobacco smokers. The investigators will use electrophysiological reactivity to smoking cues in the form of audio recordings of personalized scripts describing the scenarios associated with the strongest urges to smoke that will provide a physiological validation to a behavioral intervention. The investigators will also explore correlations between these biological markers and self report of stress, craving and negative affect to supplement self report and behavioral outcome measures with biological and physiological markers to represent improvement attributed to the intervention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional behavioral intervention | Active comparator | Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) |
| Mindfulness behavioral intervention | Active comparator | Behavioral: Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Inclusion Criteria for the entire trial:
- Inclusion criteria for the physiological assessment:
Key exclusion criteria (9 listed)
- DSM-IV diagnosis of dementia, neurodegenerative disease, or other organic mental disorder, lifetime history of psychotic disorder, bipolar disorder, severe PTSD, Dissociative Identity Disorder, OCD, anorexia nervosa, mental retardation, or autism.
- History of moderate or severe major depressive episode or generalized anxiety disorder within the last 6 months.
- Use of prescribed psychotropic medication other than SSRI/NDRI/SNRI/ buprenorphine in past 6mo, or change in such psychiatric medication dose in past six months.
- History of active substance use disorder other than nicotine or caffeine in the last 6 months.
- Positive urine toxicology for illicit drugs, alcohol, opiates or benzodiazepines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)60 smokers will enter a separate 4 wk group sessions trial that evaluates efficacy of MT in comparison to CBT for smoking cessation. During the parent study, participants will receive bi-weekly sessions of either MT or CBT, for 4 weeks and to set a quit date at the end of the 2nd week. In this context, we will examine participants at two points: * Week 0-1 of MT/CBT: development of smoking scripts based participant's descriptions of situations that trigger tobacco craving. * Then participants will undergo pre-treatment (week 0-1) and post treatment (week 4) psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues, salivary cortisol testing and to complete a computerized SST protocol. | Behavioural | Mindfulness behavioral intervention, Traditional behavioral intervention |
Primary outcome
physiologic reactivity (skin conductance, Heart rate, electromyogram, cortisol measures) to smoking cues in recently abstinent tobacco smokers
Time frame: It will be measured twice during the study: before treatment (baseline at week 0) and an average of 7 days after treatment (end point assessment)
* Wk 0: development of scripts based on participant's descriptions of the most salient aspects of the smoking experience that triggers craving. Then they will undergo pre-treatment psychophysiological activation to smoking-related cues using the script driven imagery technique (smoking-related and affectively neutral scripts), in vivo cues and salivary cortisol testing. * Wk 4: After the last MT or CBT session, participants will undergo post-treatment psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues and salivary cortisol testing.
1 secondary outcome
self reported of cue-induced negative affect, craving, and stress in recently abstinent tobacco smokers
Time frame: It will be measured twice at the baseline assessment (before and after script driven imagery) and twice at the end point assessment (before and after script driven imagery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gladys N Pachas, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT) in people with Smokers, run by A. Eden Evins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiologic reactivity (skin conductance, Heart rate, electromyogram, cortisol measures) to smoking cues in recently abstinent tobacco smokers (time frame: It will be measured twice during the study: before treatment (baseline at week 0) and an average of 7 days after treatment (end point assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.