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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DA021619 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to evaluate the use of "sampling" of smoking cessation medications (nicotine patches and lozenges) among smokers seen in primary care settings. Half of study participants will be provided with samples of medication, to use however they wish; the other half will not be provided with these samples. All smokers will be advised to quit through routine contact with their physician. After the primary care contact, all participants will be contacted by phone for three brief follow-up interviews, which will involve answering questionnaires about their smoking habits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Replacement Therapy (NRT) | Experimental | 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch |
|
| Ask, Advise, Refer (physician brief advice) | Active Comparator | Ask, Advise, Refer (physician brief advice) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapy (NRT) Sampling | Other | 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence | From study enrollment through end of six-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Any Self-defined Attempt to Stop Smoking Cigarettes | From study enrollment through end of six-month follow up | |
| Use of Any Smoking Cessation Medication | From study enrollment through end of six-month follow up |
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Inclusion Criteria:
Exclusion Criteria:
- no FDA contraindications for use of NRT:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Carpenter, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39868569 | Derived | Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2. | |
| 33828613 | Derived | Silvestri NJ, Dahne J, Wahlquist AE, Toll B, Carpenter MJ. Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial. J Smok Cessat. 2021;2021:6638872. doi: 10.1155/2021/6638872. Epub 2021 Mar 16. |
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Of 1,278 Enrolled:
32 Individuals later found to be ineligible
1 person missing contact info
1,245 = Final Intent to Treat Sample
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Ask, Advise, Refer (physician brief advice) |
| FG001 | Standard Care + Nicotine Replacement Therapy (NRT) | 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Ask, Advise, Refer (physician brief advice) |
| BG001 | Standard Care + Nicotine Replacement Therapy (NRT) | 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence | Posted | Number | percentage of participants | From study enrollment through end of six-month follow up |
|
Study consists of 3 follow-up phone calls at 1 month, 3 months, and 6 months post-baseline clinic visit. Adverse events are asked systematically of both groups, at all three follow-up calls.
Adverse Events were monitored/assessed without regard to a specific Adverse Event Term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Care | Ask, Advise, Refer (physician brief advice) | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Boatright, Program Coordinator | Medical University of South Carolina | 843-876-2440 | boatrigh@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2017 | Jun 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| C422209 | corticosteroid hormone-induced factor |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
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| Ask, Advise, Refer (physician brief advice) | Behavioral |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Heaviness of Smoking Index | HSI: Heaviness of Smoking Index (0-6 scale), where 6 indicates the highest ("worst") Heaviness of Smoking. | Mean | Standard Deviation | units on a scale |
|
| Motivation to Quit | Motivation to quit smoking in next month (0-10), where 0 indicates no desire to quit within the next month and 10 indicates full intent to quit within the next month. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Any Self-defined Attempt to Stop Smoking Cigarettes | Posted | Number | percentage of participants | From study enrollment through end of six-month follow up |
|
|
|
| Secondary | Use of Any Smoking Cessation Medication | Posted | Number | percentage of participants | From study enrollment through end of six-month follow up |
|
|
|
| 652 |
| 20 |
| 652 |
| 289 |
| 652 |
| EG001 | Standard Care + Nicotine Replacement Therapy (NRT) | 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice) Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch | 1 | 593 | 9 | 593 | 276 | 593 |
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| D006298 |
| Health Services Administration |