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Smoking CessationEarly Phase 1NCT05484505

Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan

A Early Phase 1 study testing Nicotine patch, Nicotine gums, Brief Advice (5 A's & 5 R's) and Nicotine Patch: Preloading for 4 weeks in people with Smoking Cessation and Smoking, Cigarette, run by Nazarbayev University at 2 sites in Kazakhstan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Randomized, controlled, two-armed, single-blinded, superiority trial with 1:1 allocation ratio Nicotine Replacement Therapy(NRT) Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Nicotine patch, Nicotine gums, Brief Advice (5 A's & 5 R's) and Nicotine Patch: Preloading for 4 weeks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesKazakhstan
Study dates
1 Jul 2023to 31 Dec 2024
Phase
Early Phase 1
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • all current smokers aged 18 years and above with a motivation to quit

Who cannot join

  • smokeless tobacco users, smoking frequency of fewer than 10 cigarettes per day, pregnant women, lactating women, patients with a recent history of myocardial infarction of fewer than 3 months, and electronic cigarette users

Trial locations and contacts

2 sites in 1 country.

Kazakhstan2 sites

  • National Research Cardiac Surgery Center, Astana, Kazakhstan

    Astana, 010000

    Chetan Purushothama

  • Nazarbayev University School of Medicine

    Astana, 010000

Other trials in Kazakhstan

About this study

Official title: Effectiveness of Preloaded Combination Nicotine Replacement Therapy on Smoking Cessation of Adult Population in Kazakhstan- A Randomized Controlled Trial

Randomized, controlled, two-armed, single-blinded, superiority trial with 1:1 allocation ratio Nicotine Replacement Therapy(NRT)

Read the detailed description

The primary objective is to determine the effectiveness of preloaded combination nicotine replacement therapy (NRT) on smoking cessation of tobacco smokers. The secondary objectives are to determine the predictors of smoking cessation among the study participant's, to determine the change in health-related quality of life due to smoking cessation \& to determine the perception of treatment adherence among the study participants.

Being tested
Nicotine patch, Nicotine gums, Brief Advice (5 A's & 5 R's), Nicotine Patch: Preloading for 4 weeks
Keywords
Tobacco, Smoking, Nicotine Patches, Nicotine Gums, Nicotine Replacement Therapy, Preloading
Medical subject headings
Smoking Cessation, Cigarette Smoking, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine patch, Nicotine gumsDrug

    Also called Nicotex

    Nicotine patch 21mg, 12 weeks post quit date and nicotine chewing gums 4mg for 12 weeks post quit date

    • 14 mg: Next 4 weeks
    • 7 mg: Last 4 weeks

  • Brief Advice (5 A's & 5 R's)Behavioural

    Brief Advice (5 A's \& 5 R's) at Day 0, 1 month, 3,6,9 \& 12 months

  • Nicotine Patch: Preloading for 4 weeksDrug

    Nicotine Patch: Preloading for 4 weeks - 21 mg: 4 weeks before quit date

Study groups in NCT05484505
Study groupRoleWhat they receive
Nicotine replacement therapy (NRT) PreloadingExperimental1. Brief Advice (5 A's \& 5 R's)- 0-day, Month- 1, 3, 6, 9, 12 2. a. Nicotine Replacement Therapy for > 20 cigarettes per day Nicotine Patch: Preloading for 4 weeks + 12 weeks post quit date,21 mg: 4 weeks before and after quit date,14 mg: Next 4 weeks,7 mg: Last 4 weeks Nicotine chewing gums 4 mg for 12 weeks post quit date (12/day on week 1(Tapering dose weekly)1/day on week 12 2.b. Nicotine Replacement Therapy for < 20 cigarettes per day Nicotine Patch: Preloading for 4 weeks + 12 weeks post quit date 21 mg: 4 weeks before and after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks Nicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week 1(Tapering dose)1/day on week 12
Receives: Drug: Nicotine patch, Nicotine gums; Behavioral: Brief Advice (5 A's & 5 R's); Drug: Nicotine Patch: Preloading for 4 weeks
Nicotine replacement therapy (NRT)Active comparator1. Brief Advice (5 A's \& 5 R's)- 0-day, Month- 1, 3, 6, 9, 12 2. a. Nicotine Replacement Therapy for > 20 cigarettes per day Nicotine Patch: 12 weeks post quit date 21 mg: 4 weeks after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks Nicotine chewing gums 4 mg for 12 weeks post quit date (12/day on week 1(Tapering dose weekly)1/day on week 12 2.b. Nicotine Replacement Therapy for < 20 cigarettes per day Nicotine Patch: 12 weeks post quit date 21 mg: 4 weeks after quit date 14 mg: Next 4 weeks 7 mg: Last 4 weeks Nicotine chewing gums 2 mg for 12 weeks post quit date (12/day on week 1(Tapering dose)1/day on week 12
Receives: Drug: Nicotine patch, Nicotine gums; Behavioral: Brief Advice (5 A's & 5 R's)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self reported smoking during intervention period : Yes/No

    Self-reported smoking anytime during the intervention or follow-up period

    Measured: Assessed at 12 months from the starting point of intervention.

  2. Salivary cotinine test results: Positive or Negative

    Salivary cotinine test results before, during and after the intervention

    Measured: Salivary cotinine test results before intervention, after the intervention and after follow ups

Secondary outcomes (3)

  1. Self reported number of quit attempts of tobacco

    Number of quit attempts of tobacco since enrolment

    Measured: Assessed at 3, 6 & 12 months from the starting point of intervention.

  2. Self reported number of smoked cigarettes/bidis per day

    Number of smoked cigarettes/bidis per day since enrolment

    Measured: Assessed at 12 months from the starting point of intervention.

  3. Adherence to intervention in days: Self reported

    Self reported duration of use of the intervention in days

    Measured: Assessed at 12 months from the starting point of intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start1 Jul 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484505
Sponsor's protocol ID
11022021CRP1514
Status last verified
Mar 2023
First submitted
22 Jul 2022
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data of the current study will available from the corresponding author on reasonable request.

Publications

  • Hays JT, Croghan IT, Baker CL, Cappelleri JC, Bushmakin AG. Changes in health-related quality of life with smoking cessation treatment. Eur J Public Health. 2012 Apr;22(2):224-9. doi: 10.1093/eurpub/ckq137. Epub 2010 Sep 30.

    PubMed 20884658

  • Wang Q, Mati K. Intention to Quit among Smokers in Kazakhstan: Data from 2014 Global Adult Tobacco Survey. J Epidemiol Glob Health. 2019 Mar;9(1):23-28. doi: 10.2991/jegh.k.190212.002.

    PubMed 30932386

  • Levy DT, Levy J, Mauer-Stender K. Potential impact of strong tobacco-control policies in 11 newly independent states. Cent Eur J Public Health. 2019 Jun;27(2):115-126. doi: 10.21101/cejph.a5506.

    PubMed 31241286

  • Giulietti F, Filipponi A, Rosettani G, Giordano P, Iacoacci C, Spannella F, Sarzani R. Pharmacological Approach to Smoking Cessation: An Updated Review for Daily Clinical Practice. High Blood Press Cardiovasc Prev. 2020 Oct;27(5):349-362. doi: 10.1007/s40292-020-00396-9. Epub 2020 Jun 23.

    PubMed 32578165

  • Llimargas M, Lawrence PA. Seven Wnt homologues in Drosophila: a case study of the developing tracheae. Proc Natl Acad Sci U S A. 2001 Dec 4;98(25):14487-92. doi: 10.1073/pnas.251304398. Epub 2001 Nov 20.

    PubMed 11717401

  • Prochaska JJ. Nicotine Replacement Therapy as a Maintenance Treatment. JAMA. 2015 Aug 18;314(7):718-9. doi: 10.1001/jama.2015.7460.

    PubMed 26284723

  • Chai W, Zou G, Shi J, Chen W, Gong X, Wei X, Ling L. Evaluation of the effectiveness of a WHO-5A model based comprehensive tobacco control program among migrant workers in Guangdong, China: a pilot study. BMC Public Health. 2018 Feb 27;18(1):296. doi: 10.1186/s12889-018-5182-6.

    PubMed 29486753

  • Dhavan P, Bassi S, Stigler MH, Arora M, Gupta VK, Perry CL, Ramakrishnan L, Reddy KS. Using salivary cotinine to validate self-reports of tobacco use by Indian youth living in low-income neighborhoods. Asian Pac J Cancer Prev. 2011;12(10):2551-4.

    PubMed 22320954

  • Rose JE, Behm FM, Westman EC. Nicotine-mecamylamine treatment for smoking cessation: the role of pre-cessation therapy. Exp Clin Psychopharmacol. 1998 Aug;6(3):331-43. doi: 10.1037//1064-1297.6.3.331.

    PubMed 9725117

  • Hymowitz N, Cummings KM, Hyland A, Lynn WR, Pechacek TF, Hartwell TD. Predictors of smoking cessation in a cohort of adult smokers followed for five years. Tob Control. 1997;6 Suppl 2(Suppl 2):S57-62. doi: 10.1136/tc.6.suppl_2.s57.

    PubMed 9583654

  • Purushothama C, Crape BL, Stolyarov V, Jaxybayeva A, la Fleur P, Olickal JJ. Preloaded combination nicotine replacement therapy for smoking cessation in Kazakhstan: A randomized controlled trial study protocol. PLoS One. 2023 Nov 27;18(11):e0292490. doi: 10.1371/journal.pone.0292490. eCollection 2023.

    PubMed 38011129

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Nicotine patch, Nicotine gums, Brief Advice (5 A's & 5 R's) and Nicotine Patch: Preloading for 4 weeks in people with Smoking Cessation and Smoking, Cigarette, run by Nazarbayev University at 2 sites in Kazakhstan.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kazakhstan. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Self reported smoking during intervention period : Yes/No (time frame: Assessed at 12 months from the starting point of intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484505, which also lists 11 linked publications.

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 24 Mar 2023.

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