Clinical trial • Phase II • Psychiatry
nicotine for Nicotine dependence
Phase II trial of nicotine for Nicotine dependence.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Nicotine dependence
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 26-09-2025
- First CTIS Authorization Date
- 17-11-2025
Trial design
Randomised, open-label, nicotine pouch (np) dry 4 mg; nicorette® lozenge 4 mg; three-way crossover design (third treatment arm not specified in provided data)-controlled, crossover Phase II trial across 2 sites in Sweden.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Nicotine pouch (NP) dry 4 mg; Nicorette® lozenge 4 mg; three-way crossover design (third treatment arm not specified in provided data)
- Crossover
- Yes
- Target Sample Size
- 72
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 5
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 72
Sweden
- Earliest CTIS Part Ii Submission Date
- 07-11-2025
- Latest Decision Or Authorization Date
- 17-11-2025
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 72
Sites
- Site Name
- Vetenskapens Graend 11
- Department Name
- CTC GoCo
- Contact Person Name
- Kaj Stenlöf
- Contact Person Email
- kaj.stenlof@medfak.gu.se
- Site Name
- Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors.
- Department Name
- CTC Oscar
- Contact Person Name
- Johan Nilsson
- Contact Person Email
- johan.nilsson@ctc-ab.se
Sponsor
Primary sponsor
- Full Name
- Swedish Match North Europe AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Contract research organisations
- Name
- CTC Clinical Trial Consultants AB
- Responsibilities
- Listed as trial site / organisationAddressInfo (site operations)
Investigational products
- Investigational Product Name
- nicotine pouch (NP) dry 4 mg
- Active Substance
- nicotine
- Modality
- Small molecule
- Routes Of Administration
- oral (pouch)
- Route
- oral (pouch)
- Starting Dose
- 4 mg
- Dose Levels
- 4 mg (single dose)
- Frequency
- single-dose
- Maximum Dose
- 4 mg
- Investigational Product Name
- Nicorette® lozenge 4 mg
- Active Substance
- nicotine
- Modality
- Small molecule
- Routes Of Administration
- oral (lozenge)
- Route
- oral (lozenge)
- Starting Dose
- 4 mg
- Dose Levels
- 4 mg (single dose)
- Frequency
- single-dose
- Maximum Dose
- 4 mg
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