Smoking CessationNCT01684995
Motivation and Nicotine Patch Treatment for Under-served Smokers
A study testing Brief physician advice, nicotine patch and Individually Tailored Behavioral Skills training in people with Smoking Cessation, run by The Miriam Hospital at 1 site in United States.
Trial summary
The goal of this study is to test, in combination with the nicotine patch, the incremental efficacy of a motivationally tailored behavioral intervention over a minimal intervention. The interventions will be delivered through primary care medical clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Brief physician advice, nicotine patch and Individually Tailored Behavioral Skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 1996to Nov 1999
- Phase
- Interventional
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Currently smoking at least 10 cigarettes/day for past 3 months
- Speak English or Spanish
- Have a telephone or live close to a relative or neighbor with a telephone
- Agree to participate in the study and be available over the next 6 months.
Who cannot join
- Unable to use nicotine patch due to medical status
- Active skin condition or history of skin allergy
- Currently using smokeless tobacco, nicotine replacement or other smoking cessation treatment
- Pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to test, in combination with the nicotine patch, the incremental efficacy of a motivationally tailored behavioral intervention over a minimal intervention. The interventions will be delivered through primary care medical clinics. The defined population comprises low income, less educated smokers who will vary in their level of motivation to quit smoking. Patients will be randomly assigned within clinics to one of two interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored motivational intervention, a behavioral skills counseling session for smoking cessation.
- Conditions
- Smoking Cessation
- Being tested
- Brief physician advice, nicotine patch, Individually Tailored Behavioral Skills training
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief physician adviceBehavioural
Brief physician advice to quit smoking
nicotine patchDrug
nicotine patch
Individually Tailored Behavioral Skills trainingBehavioural
Individually tailored behavioral skills training for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Minimal | Active comparator | Brief physician advice to quit smoking plus nicotine patch Receives: Behavioral: Brief physician advice; Drug: nicotine patch |
| Tailored | Experimental | Not described Receives: Behavioral: Brief physician advice; Drug: nicotine patch; Behavioral: Individually Tailored Behavioral Skills training |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startDec 1996
- Primary completionNov 1999
- Study completionNov 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684995
- Sponsor's protocol ID
- Quit_RIte_RI
- Other IDs
- R01DA010860
- Status last verified
- Aug 2012
- First submitted
- 29 Aug 2012
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bock B, Lopes CE, van den Berg JJ, Roberts MB, Stein LA, Martin RA, Martin SA, Clarke JG. Social support and smoking abstinence among incarcerated adults in the United States: a longitudinal study. BMC Public Health. 2013 Sep 17;13:859. doi: 10.1186/1471-2458-13-859.
PubMed 24044880
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivation and Nicotine Patch Treatment for Under-served Smokers
- ClinicalTrials.gov ID
- NCT01684995
- Acronym / sponsor ID
- Quit_RIte_RI
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 1996
- Primary completion
- Nov 1999 (actual)
- Study completion
- Nov 1999 (actual)
- First posted
- 13 Sep 2012 (estimated)
- 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.
The goal of this study is to test, in combination with the nicotine patch, the incremental efficacy of a motivationally tailored behavioral intervention over a minimal intervention. The interventions will be delivered through primary care medical clinics. The defined population comprises low income, less educated smokers who will vary in their level of motivation to quit smoking. Patients will be randomly assigned within clinics to one of two interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored motivational intervention, a behavioral skills counseling session for smoking cessation.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal | Active comparator | Behavioral: Brief physician advice, Drug: nicotine patchBrief physician advice to quit smoking plus nicotine patch |
| Tailored | Experimental | Behavioral: Brief physician advice, Drug: nicotine patch, Behavioral: Individually Tailored Behavioral Skills training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Currently smoking at least 10 cigarettes/day for past 3 months
- Speak English or Spanish
- Have a telephone or live close to a relative or neighbor with a telephone
- Agree to participate in the study and be available over the next 6 months.
Key exclusion criteria (4 listed)
- Unable to use nicotine patch due to medical status
- Active skin condition or history of skin allergy
- Currently using smokeless tobacco, nicotine replacement or other smoking cessation treatment
- Pregnant or nursing
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 |
|---|---|---|
| Brief physician adviceBrief physician advice to quit smoking | Behavioural | Minimal, Tailored |
| nicotine patchnicotine patch | Drug | Minimal, Tailored |
| Individually Tailored Behavioral Skills trainingIndividually tailored behavioral skills training for smoking cessation | Behavioural | Tailored |
Primary outcome
Not reported in the source record.
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 13 Sep 2012.
- Derived from this study: PubMed 24044880Bock B, Lopes CE, van den Berg JJ, Roberts MB, Stein LA, Martin RA, Martin SA, Clarke JG. Social support and smoking abstinence among incarcerated adults in the United States: a longitudinal study. BMC Public Health. 2013 Sep 17;13:859. doi: 10.1186/1471-2458-13-859.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief physician advice, nicotine patch and Individually Tailored Behavioral Skills training in people with Smoking Cessation, run by The Miriam Hospital 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 5 inclusion and 4 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 13 Sep 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684995, which also lists 1 linked publication.
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 13 Sep 2012.