Smoking CessationPhase 2NCT04035603
Multimodal Cue Exposure Therapy for Smoking Cessation
A Phase 2 study testing D-Cycloserine, Open Phase CBT that preceeds the randomization phase and Open phase smoking cessation pharmacotherapy that proceeds the randomization phase in people with Smoking Cessation, run by Boston University Charles River Campus.
Trial summary
At two sites (Boston University and the University of Texas at Austin, under the MPI direction of Drs. Otto and Smits) the investigators propose to randomly assign 240 adult smokers who have achieved short-term abstinence following open treatment with a 4 session cognitive-behavior therapy program combined with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- D-Cycloserine, Open Phase CBT that preceeds the randomization phase and Open phase smoking cessation pharmacotherapy that proceeds the randomization phase
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 31 Jan 2021
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- daily smoker for at least one year, smoking an average of at least 10 cigarettes per day, and motivated to quit smoking (>5 on a 10 point scale)
- had reactivity to in vivo smoking cues (an increase of two points or maximal score of 10 on a 10 point visual analogue craving scale [VAS]) following no smoking for a minimum of two hours
- medical clearance to participate in the protocol
Who cannot join
- use of other tobacco products
- current unstable medical illness (i.e. deemed as at high risk of significant worsening by study intervention procedures by study physician; e.g. heart disease, chronic obstructive pulmonary disease, or seizure disorders - assessed during telephone prescreen and initial assessment), seizure disorder, pregnancy, breastfeeding, or use of isoniazid or ethionamide
- lifetime history of psychotic disorders or uncontrolled bipolar disorder, by DSM-5 criteria as assessed by the MIni International Neuropsychiatric Interview
- substance use disorder other than nicotine or caffeine active in the past 6 months, or excessive concurrent alcohol use as defined by self-report of an average of >21 standardized drinks per week for males or >14 standardized drinks per week for females
- elevated suicide risk as determined by clinician interview
- current use of any psychotropic medications or pharmacotherapy or psychotherapy for smoking cessation not provided by the investigators during the quit attempt
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- known hypersensitivity to DCS
- insufficient command of the English language or inability to understand study procedures and participate in the informed consent process
- To progress to the randomized phase:
- participants must achieve a 24 hour abstinence period
About this study
Official title: Multimodal CET for Smoking Cessation Augmented With D-cycloserine
At two sites (Boston University and the University of Texas at Austin, under the MPI direction of Drs. Otto and Smits) the investigators propose to randomly assign 240 adult smokers who have achieved short-term abstinence following open treatment with a 4 session cognitive-behavior therapy program combined with medication (nicotine patch, varenicline, or bupropion, selected openly) to (1) d-cycloserine augmentation of multimodal cue exposure therapy (CET), or (2) placebo augmentation of multimodal CET. This Stage II project is designed to: (1) evaluate the short-term and long-term efficacy of the experimental intervention, (2) further test putative mechanisms of change, (3) explore possible moderator effects of theoretically-relevant variables, and (4) use innovative, multimodal CET strategies. Putative mediators and smoking abstinence will be assessed during the intervention period and up to 6 months following the quit attempt.
Read the detailed description
This study utilizes on open phase of 4-sessions of cognitive-behavior therapy for smoking cessation that is combined with open pharmacotherapy (selected by participants in collaboration with the study medical team: nicotine patch, varenicline, or bupropion). Session topics include educational (e.g., health risks of smoking, effectiveness of different treatment approaches), motivational enhancement (e.g., identifying personally relevant benefits of quitting, and costs of continuing to smoke), and cognitive-behavioral elements (e.g., identifying smoking triggers, developing coping strategies for these triggers, planning for high risk situations, relapse prevention). The study therapists will also make a supportive phone call on the day of the quit attempt, with repeated check-in calls over the quit window (i.e., weeks 4-6) as needed for individuals having difficulties reaching abstinence. Participants who fail to achieve smoking cessation during the quit period window will be referred for clinical treatment as desired in the center the study is conducted in or an alternative site.
Following successful smoking abstinence at Week 0 (Week 0 is defined by 24 hr abstinence within a two-week grace period of the target date), participants will be randomized to the study drug condition (50 mg DCS or matching placebo) combined with cue-exposure therapy (CET). CET is manualized and will have four modalities: (1) exposure to slides of smoking (pictorial), (2) exposure to emotions and imagined situations that most reliably trigger an urge to smoke (emotional/imaginal), (3) exposure to a participant's own cigarettes and pack (in vivo),70 and (4) personalized and immersive 360° VR exposure (participants select the VR scene-e.g., break time outside work, evening party, car ride that best corresponds to their highest craving situation). CET sessions are scheduled for the quit week, one week later, and again 8 weeks later. Smoking cessation assessments continue across 24 weeks of follow-up.
- Conditions
- Smoking Cessation
- Being tested
- D-Cycloserine, Placebo oral tablet, Open Phase CBT that preceeds the randomization phase, Open phase smoking cessation pharmacotherapy that proceeds the randomization phase
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-CycloserineDrug
Also called DCS
50 mg d-cycloserine given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment.
Placebo oral tabletDrug
Also called PBO
matching 50 mg identical placebo given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment.
Open Phase CBT that preceeds the randomization phaseBehavioural
Four sessions of weekly individual cognitive-behavior therapy (CBT: a form of psychotherapy that treats problems by helping people modify thoughts, behaviors, and emotions; in this case, for the goal of smoking cessation). Session topics include educational (e.g., health risks of smoking, effectiveness of different treatment approaches), motivational enhancement (e.g., identifying personally relevant benefits of quitting, and costs of continuing to smoke), and cognitive-behavioral elements (e.g., identifying smoking triggers, developing coping strategies for these triggers, planning for high risk situations, relapse prevention).
Open phase smoking cessation pharmacotherapy that proceeds the randomization phaseDrug
Initiating 2 weeks prior to quit date and continuing for 8 weeks after quit date, choice of one of three pharmacological smoking cessation aids: Nicotine Replacement Therapy (nicotine patch), Varenicline, or Bupropion.
| Study group | Role | What they receive |
|---|---|---|
| D-Cycloserine Augmentation | Experimental | D-cycloserine (DCS) augmentation of CET sessions Receives: Drug: D-Cycloserine; Behavioral: Open Phase CBT that preceeds the randomization phase; Drug: Open phase smoking cessation pharmacotherapy that proceeds the randomization phase |
| Placebo Augmentation | Placebo comparator | Placebo (PBO) augmentation of CET sessions Receives: Drug: Placebo oral tablet; Behavioral: Open Phase CBT that preceeds the randomization phase; Drug: Open phase smoking cessation pharmacotherapy that proceeds the randomization phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Prolonged Abstinence (PA)
Failure to maintain PA at any assessment will be defined by 7 or more consecutive days of smoking or smoking at least 1 cigarette over the 2 consecutive weeks prior to the assessment
Measured: Prolonged abstinence is assessed from Quit week to Week 24 of Follow-up
Rates of Point Prevalence Abstinence (PPA)
PPA is defined as no smoking in the 7 days prior to any assessment. Self-report is verified with saliva cotinine.
Measured: Point Prevalence Abstinence is assessed from Quit Week to 24 week Follow-up using a growth curve model
Secondary outcomes (1)
Cue-Induces Patient Rating of Craving for Cigarettes
Cravings in response to visual, in vivo, imaginal, and VR smoking cues rated according to a 0 to 11 visual analogue scale; higher scores represent higher craving levels.
Measured: Post-quit weeks 0, 1, 2, 9, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Oct 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Why it stopped: Never received funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Michael Otto, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035603
- Sponsor's protocol ID
- R01DA048043
- Status last verified
- Feb 2021
- First submitted
- 19 Jun 2019
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: One year after publication of the primary aims from this project the primary and fully de-identified IPD will be made available by the investigators on CD for other researchers providing documented IRB consent from their institution.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal CET for Smoking Cessation Augmented With D-cycloserine
- ClinicalTrials.gov ID
- NCT04035603
- Acronym / sponsor ID
- R01DA048043
- Conditions
- Smoking Cessation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never received funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 29 Jul 2019 (actual)
- 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.
At two sites (Boston University and the University of Texas at Austin, under the MPI direction of Drs. Otto and Smits) the investigators propose to randomly assign 240 adult smokers who have achieved short-term abstinence following open treatment with a 4 session cognitive-behavior therapy program combined with medication (nicotine patch, varenicline, or bupropion, selected openly) to (1) d-cycloserine augmentation of multimodal cue exposure therapy (CET), or (2) placebo augmentation of multimodal CET. This Stage II project is designed to: (1) evaluate the short-term and long-term efficacy of the experimental intervention, (2) further test putative mechanisms of change, (3) explore possible moderator effects of theoretically-relevant variables, and (4) use innovative, multimodal CET strategies. Putative mediators and smoking abstinence will be assessed during the intervention period and up to 6 months following the quit attempt.
Detailed description
This study utilizes on open phase of 4-sessions of cognitive-behavior therapy for smoking cessation that is combined with open pharmacotherapy (selected by participants in collaboration with the study medical team: nicotine patch, varenicline, or bupropion). Session topics include educational (e.g., health risks of smoking, effectiveness of different treatment approaches), motivational enhancement (e.g., identifying personally relevant benefits of quitting, and costs of continuing to smoke), and cognitive-behavioral elements (e.g., identifying smoking triggers, developing coping strategies for these triggers, planning for high risk situations, relapse prevention). The study therapists will also make a supportive phone call on the day of the quit attempt, with repeated check-in calls over the quit window (i.e., weeks 4-6) as needed for individuals having difficulties reaching abstinence. Participants who fail to achieve smoking cessation during the quit period window will be referred for clinical treatment as desired in the center the study is conducted in or an alternative site.
Following successful smoking abstinence at Week 0 (Week 0 is defined by 24 hr abstinence within a two-week grace period of the target date), participants will be randomized to the study drug condition (50 mg DCS or matching placebo) combined with cue-exposure therapy (CET). CET is manualized and will have four modalities: (1) exposure to slides of smoking (pictorial), (2) exposure to emotions and imagined situations that most reliably trigger an urge to smoke (emotional/imaginal), (3) exposure to a participant's own cigarettes and pack (in vivo),70 and (4) personalized and immersive 360° VR exposure (participants select the VR scene-e.g., break time outside work, evening party, car ride that best corresponds to their highest craving situation). CET sessions are scheduled for the quit week, one week later, and again 8 weeks later. Smoking cessation assessments continue across 24 weeks of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Cycloserine Augmentation | Experimental | Drug: D-Cycloserine, Behavioral: Open Phase CBT that preceeds the randomization phase, Drug: Open phase smoking cessation pharmacotherapy that proceeds the randomization phaseD-cycloserine (DCS) augmentation of CET sessions |
| Placebo Augmentation | Placebo comparator | Drug: Placebo oral tablet, Behavioral: Open Phase CBT that preceeds the randomization phase, Drug: Open phase smoking cessation pharmacotherapy that proceeds the randomization phasePlacebo (PBO) augmentation of CET sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- daily smoker for at least one year, smoking an average of at least 10 cigarettes per day, and motivated to quit smoking (>5 on a 10 point scale)
- had reactivity to in vivo smoking cues (an increase of two points or maximal score of 10 on a 10 point visual analogue craving scale [VAS]) following no smoking for a minimum of two hours
- medical clearance to participate in the protocol
Key exclusion criteria (10 listed)
- use of other tobacco products
- current unstable medical illness (i.e. deemed as at high risk of significant worsening by study intervention procedures by study physician; e.g. heart disease, chronic obstructive pulmonary disease, or seizure disorders - assessed during telephone prescreen and initial assessment), seizure disorder, pregnancy, breastfeeding, or use of isoniazid or ethionamide
- lifetime history of psychotic disorders or uncontrolled bipolar disorder, by DSM-5 criteria as assessed by the MIni International Neuropsychiatric Interview
- substance use disorder other than nicotine or caffeine active in the past 6 months, or excessive concurrent alcohol use as defined by self-report of an average of >21 standardized drinks per week for males or >14 standardized drinks per week for females
- elevated suicide risk as determined by clinician interview
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 |
|---|---|---|
| D-CycloserineAlso: DCS50 mg d-cycloserine given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment. | Drug | D-Cycloserine Augmentation |
| Placebo oral tabletAlso: PBOmatching 50 mg identical placebo given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment. | Drug | Placebo Augmentation |
| Open Phase CBT that preceeds the randomization phaseFour sessions of weekly individual cognitive-behavior therapy (CBT: a form of psychotherapy that treats problems by helping people modify thoughts, behaviors, and emotions; in this case, for the goal of smoking cessation). Session topics include educational (e.g., health risks of smoking, effectiveness of different treatment approaches), motivational enhancement (e.g., identifying personally relevant benefits of quitting, and costs of continuing to smoke), and cognitive-behavioral elements (e.g., identifying smoking triggers, developing coping strategies for these triggers, planning for high risk situations, relapse prevention). | Behavioural | D-Cycloserine Augmentation, Placebo Augmentation |
| Open phase smoking cessation pharmacotherapy that proceeds the randomization phaseInitiating 2 weeks prior to quit date and continuing for 8 weeks after quit date, choice of one of three pharmacological smoking cessation aids: Nicotine Replacement Therapy (nicotine patch), Varenicline, or Bupropion. | Drug | D-Cycloserine Augmentation, Placebo Augmentation |
Primary outcome
Rates of Prolonged Abstinence (PA)
Time frame: Prolonged abstinence is assessed from Quit week to Week 24 of Follow-up
Failure to maintain PA at any assessment will be defined by 7 or more consecutive days of smoking or smoking at least 1 cigarette over the 2 consecutive weeks prior to the assessment
Rates of Point Prevalence Abstinence (PPA)
Time frame: Point Prevalence Abstinence is assessed from Quit Week to 24 week Follow-up using a growth curve model
PPA is defined as no smoking in the 7 days prior to any assessment. Self-report is verified with saliva cotinine.
1 secondary outcome
Cue-Induces Patient Rating of Craving for Cigarettes
Time frame: Post-quit weeks 0, 1, 2, 9, and 10
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: Yes. One year after publication of the primary aims from this project the primary and fully de-identified IPD will be made available by the investigators on CD for other researchers providing documented IRB consent from their institution.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-Cycloserine, Open Phase CBT that preceeds the randomization phase and Open phase smoking cessation pharmacotherapy that proceeds the randomization phase in people with Smoking Cessation, run by Boston University Charles River Campus.
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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Rates of Prolonged Abstinence (PA) (time frame: Prolonged abstinence is assessed from Quit week to Week 24 of Follow-up). The study lists 2 primary outcomes in all. 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 12 Feb 2021.