Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Browse trials for

• Smoking 325
• Smoking Cessation 350

Keywords

• Nicotine
• Nicotine craving

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 187 is above the median of 117 across 250 interventional studies indexed under Smoking.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Study arms

• Active comparator
  Lower dose Nicotine

  lower dose nicotine lozenge

  Drug: Nicotine lower dose

• Active comparator
  Higher dose Nicotine

  higher dose Nicotine lozenge

  Drug: Nicotine higher dose

• Placebo comparator
  Placebo

  Placebo

  Drug: Placebo

Interventions

• DrugNicotine lower dose

  lower dose nicotine lozenge

• DrugNicotine higher dose

  higher dose nicotine lozenge

• DrugPlacebo

  placebo

Primary outcomes

1. Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers

   Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.

   Time frame: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment

2. Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers

   Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.

   Time frame: Baseline, 3 minutes and 15 minutes post-treatment

Secondary outcomes

1. Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group

   Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.

   Time frame: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm

2. Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

   AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.

   Time frame: Baseline, 0 minute, 60 minutes and 5 days post treatment

Baseline characteristics

Publications

• Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7. PubMed 29663982 ↗

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Data sharing details ↗ · clinicalstudydatarequest.com