Clinical trial NCT05881304: Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Official title: Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Electronic Cigarette Use
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-05-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day \[primary outcome\], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control \[WLC\]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC).


Eligibility criteria: Inclusion Criteria:

* 18 years of age

  * Report daily cigarette smoking (\>=10 cigarettes per day in the past week)
  * Not ready to quit smoking (not planning to quit in the next 30 days)
  * Willing to try e-cigarettes
  * In stable buprenorphine (BUP) treatment for opioid use disorder at an Massachusetts General Hospital-affiliated primary care clinic (in treatment for \>=3 months without changes in BUP dose in the past 2 weeks and planning to remain on current BUP treatment for \>=3 months).

Exclusion Criteria:

* Pregnant or breastfeeding
* Using non-cigarette nicotine or tobacco products (e.g., e-cigarettes, cigarillos) recently (\>3 days in past 30 days)
* Report past 30-day use of behavioral or pharmacologic smoking cessation aids
* Deemed inappropriate for participation by their OUD provider
* Have an unstable psychiatric (e.g., past month suicidal ideation, active psychosis) or medical condition (e.g., life expectancy \<1 year).

Primary outcomes:
measure: Cigarettes smoked per day
timeFrame: Baseline 2 to 8 weeks
Secondary outcomes:
measure: Study enrollment
timeFrame: Baseline
measure: E-cigarette use during e-cigarette provision
timeFrame: During the 8 weeks of e-cigarette provision
measure: Breath carbon monoxide
timeFrame: Baseline 1-Week 8
measure: Anabasine
timeFrame: Baseline 1-Week 8
measure: Study completion
timeFrame: Baseline 2-12 weeks for iSREC (Baseline 2-20 weeks for WLC)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joanna M Streck, PhD
role: PRINCIPAL_INVESTIGATOR
References: