SmokingSCORNCT03885336
Couples Dynamics and Smoking Cessation
An observational study of Smoking and Smoking Cessation, run by University of Southern California at 1 site in United States.
Trial summary
This study is about investigating smoking and attempts to quit smoking in couples. Participation will help determine better treatment efforts for couples who want to quit smoking. All study procedures will be conducted remotely, allowing couples to interact with study personnel through zoom. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking, Smoking Cessation, Cessation, Smoking
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2018to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Participants may live through the United States.
Who may be able to join
- Couples must be in a relationship for more than 6 months with no plans to separate or move in the next 30 days.
- Participants must smoke at least 5 cigarettes per day for at least the past 2 years.
Who cannot join
- English non-fluency.
- Currently pregnant, nursing, or intend to become pregnant within the next 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
Official title: Interpersonal Mechanisms of Smoking Relapse in Romantic Couples
This study is about investigating smoking and attempts to quit smoking in couples. Participation will help determine better treatment efforts for couples who want to quit smoking. All study procedures will be conducted remotely, allowing couples to interact with study personnel through zoom.
- Being tested
- No Interventions
- Medical subject headings
- Smoking, Smoking Cessation, Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
There are no interventions in this study. Participants are observed.
| Study group | Role | What they receive |
|---|---|---|
| Both-Quit Group | Couples in which both individuals smoke and both individuals would like to quit smoking. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette Craving
This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges.
Measured: Throughout study completion, an average of 28 days
Confidence in Quit Attempt
This measure is obtained through the completion of the Abstinence Self-Efficacy Questionnaire.
Measured: Throughout study completion, an average of 28 days
Mood
This measure is obtained through the completion of the Profile of Mood States Questionnaire.
Measured: Throughout study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start26 Aug 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Matthew Kirkpatrick, University of Southern California
- Investigators
- Matthew Kirkpatrick, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885336
- Sponsor's protocol ID
- HS-16-00898
- Acronym
- SCOR
- Status last verified
- Apr 2023
- First submitted
- 6 Mar 2019
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpersonal Mechanisms of Smoking Relapse in Romantic Couples
- ClinicalTrials.gov ID
- NCT03885336
- Acronym / sponsor ID
- SCOR / HS-16-00898
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 26 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Mar 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.
This study is about investigating smoking and attempts to quit smoking in couples. Participation will help determine better treatment efforts for couples who want to quit smoking. All study procedures will be conducted remotely, allowing couples to interact with study personnel through zoom.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Both-Quit Group | – | Other: No InterventionsCouples in which both individuals smoke and both individuals would like to quit smoking. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants may live through the United States.
Key inclusion criteria (2 listed)
- Couples must be in a relationship for more than 6 months with no plans to separate or move in the next 30 days.
- Participants must smoke at least 5 cigarettes per day for at least the past 2 years.
Key exclusion criteria (2 listed)
- English non-fluency.
- Currently pregnant, nursing, or intend to become pregnant within the next 6 months.
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 |
|---|---|---|
| No InterventionsThere are no interventions in this study. Participants are observed. | Other | Both-Quit Group |
Primary outcome
Cigarette Craving
Time frame: Throughout study completion, an average of 28 days
This measure is obtained through the completion of the Brief Questionnaire of Smoking Urges.
Confidence in Quit Attempt
Time frame: Throughout study completion, an average of 28 days
This measure is obtained through the completion of the Abstinence Self-Efficacy Questionnaire.
Mood
Time frame: Throughout study completion, an average of 28 days
This measure is obtained through the completion of the Profile of Mood States Questionnaire.
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 20 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Matthew Kirkpatrick, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking Cessation, run by University of Southern California 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 2 inclusion and 2 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 20 Apr 2023. 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.
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?
Cigarette Craving (time frame: Throughout study completion, an average of 28 days). The study lists 3 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 20 Apr 2023.