Multimodal Cue Exposure Therapy for Smoking Cessation

NCT04035603 | Withdrawn Phase 2 DMC

• 1 other identifier: R01DA048043
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  Post-quit weeks 0, 1, 2, 9, and 10

Study Arms (2)

D-Cycloserine Augmentation

EXPERIMENTAL

D-cycloserine (DCS) augmentation of CET sessions

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

Drug: Placebo oral tablet; Behavioral: Open Phase CBT that preceeds the randomization phase; Drug: Open phase smoking cessation pharmacotherapy that proceeds the randomization phase

Interventions

D-Cycloserine DRUG

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.

Also known as: DCS

D-Cycloserine Augmentation

Placebo oral tablet DRUG

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.

Also known as: PBO

Placebo Augmentation

Open Phase CBT that preceeds the randomization phase BEHAVIORAL

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).

D-Cycloserine Augmentation; Placebo Augmentation

Open phase smoking cessation pharmacotherapy that proceeds the randomization phase DRUG

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.

D-Cycloserine Augmentation; Placebo Augmentation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Smoking Cessation

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 29, 2019
• Study Start: October 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: One year after publication of primary aims
• Access Criteria: Institutional IRB approval