E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tobacco dependence/smoking cessation |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Health Care [N] - Environment and Public Health [N06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057852 |
E.1.2 | Term | Nicotine dependence |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008374 |
E.1.2 | Term | Cessation of smoking |
E.1.2 | System Organ Class | 100000004869 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of the study is to compare abstinence rates at end of pregnancy between the two different treatment arms: nicotine patches and EC. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess safety of EC when used to help pregnant smokers stop smoking compared to safety of nicotine patches; to assess effects of the two interventions on changes in smoke intake and in nicotine intake, effects on short-term abstinence; and adherence to each treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Daily smokers 12 to 24 weeks pregnant Wants help with stopping smoking Willing to be randomised to use either NRT or EC (to avoid selective drop-out and contamination) Wiling to receive 6 weekly support calls over the phone plus two follow-up calls Speaks and reads English to a level that permits data collection via the telephone.
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E.4 | Principal exclusion criteria |
Known allergic reaction to nicotine skin patches (a contraindication for patch use) Current daily use of NRT or EC Taking part in another interventional trial (as per Good Clinical Practice) Serious medical problem or high-risk pregnancy at time of initial consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Prolonged abstinence from smoking from two weeks after the Target Quit Date (TQD) until the end of pregnancy, defined as per Russell Standard (up to five lapses allowed with no smoking at all during the previous week at the time of final follow-up and validated by salivary cotinine (< 15 ng/ml) for those not reporting using any nicotine product and anabasine (< 1 ng/ml) for those reporting other forms of nicotine use. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From 35 weeks gestation to 3 months post-partum |
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E.5.2 | Secondary end point(s) |
Changes in smoke intake and in nicotine intake indexed by salivary anabasine and salivary cotinine levels, assessed for participants still using NRT or EC at end of pregnancy and for ‘dual users’; 7-day point-prevalence abstinence self-reported at 4 weeks, end of pregnancy and at 3 months post-partum; self-reported prolonged abstinence at end of pregnancy and 3 months post-partum; use of NRT and EC throughout pregnancy; proportion of participants reporting adverse events and serious adverse events in each group; proportion of participants in each group reporting adverse events and serious adverse events for themselves or their infant at 3 months post-partum; birth and maternal outcomes. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Changes in smoke intake and in nicotine intake: end of pregnancy - 7-day point-prevalence abstinence self-reported: at 4 weeks, end of pregnancy and at 3 months post-partum. - use of NRT and EC: from target-quit day to 3 months post-partum - self-reported prolonged abstinence: end of pregnancy and 3 months post-partum - proportion of participants reporting adverse events and serious adverse events in each group: from start of product use to 3 months post-partum - proportion of infant related adverse events and serious adverse events in each group: at 3 months post-partum - birth and maternal outcomes: at end of pregnancy
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 33 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study would be completed and the REC informed, 6 months after the final participant has been followed up for their 3m post-partum follow-up, to allow for saliva sample analysis to be completed.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |