BridgeMD
New treatment option for Nicotine Dependence
Official title Smart Olfaction App to Reduce Relapse
ClinicalTrials.gov ID: NCT07007195
What this study is testing
What is Nicotine replacement therapy (NRT)?
Nicotine replacement therapy (NRT) is an investigational medicine, given as an once-daily, being studied as a potential treatment for nicotine dependence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The proposed project aims to refine and test a novel biobehavioral smoking cessation intervention that integrates the strategic application of olfactory stimulation to reduce cigarette craving with an established smartphone-based smoking cessation application. The specific aims of this study are: (1) refine the design and methodology of our olfactory stimulation delivery system (OSDS) and (2) compare, in a pilot randomized controlled trial (RCT), the effects of a smartphone based app for smoking cessation (Smart-T) with and without the OSDS on smoking cessation outcomes.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- At least 18 years of age
- Ability to read, understand and speak English
- Currently smoke at least 5 cigarettes daily for one year or longer
- Do not currently smoke marijuana or currently smoke marijuana but willing to not smoke during the duration of the study
- Did not use electronic cigarette or vaping device in the past 90 days
You likely can't join if
- Olfactory dysfunction including inability to smell, a very weak or distorted sense of smell, or sensitivity to odors
- Report any allergies or negative reactions to odors/fragranced products
- Being pregnant, breastfeeding, or planning to become pregnant within the next month
- Report hypertension that is not under control
- Have had a heart attack within the past two weeks
- Those who participated in Phase I will not be eligible to participate in Phase II
See the full eligibility criteria
- At least 18 years of age
- Ability to read, understand and speak English
- Currently smoke at least 5 cigarettes daily for one year or longer
- Do not currently smoke marijuana or currently smoke marijuana but willing to not smoke during the duration of the study
- Did not use electronic cigarette or vaping device in the past 90 days
- Have an active smartphone that is Apple or Android based
- Have phone service including a data plan
- Interested in downloading the study app onto their personal phone
- Motivated to quit smoking
- English literacy of 7th grade or higher, as indicated by a score of ≥ 4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF)
- Biochemical verification of smoking status
- Proof of smoking status at enrollment via photo of cigarettes
- Presents a photo ID that matches the information on screener survey
- Willing and able to complete study procedures
- Willing to use NRT and quit smoking for 14 days (Phase I) or willing to use NRT and quit smoking for 13 weeks (Phase II)
- Olfactory dysfunction including inability to smell, a very weak or distorted sense of smell, or sensitivity to odors
- Report any allergies or negative reactions to odors/fragranced products
- Being pregnant, breastfeeding, or planning to become pregnant within the next month
- Report hypertension that is not under control
- Have had a heart attack within the past two weeks
- Those who participated in Phase I will not be eligible to participate in Phase II
- Have a smartphone that is not compatible with the Insight mHealth platform
- Report using electronic cigarette or vaping device in the past 90 days
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.