Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 18 of 18

List	Outcome	Time frame	Description
Primary	The Gambling Symptom Assessment Scale (G-SAS) gambling symptom severity and change during the treatment - assessment	Baseline to week, 3, 6, 9 and week 12.	The G-SAS is a 12-item self-rated scale designed to assess gambling symptom severity and change during treatment. The G-SAS is not a diagnostic or screening instrument. Each 12-item scale has a score ranging from 0 - 4 (adjective anchors for 0 and 4 vary for each item). All items ask for an average symptom based on the past 7 days. Items 1 - 4 can be used to assess changes in craving symptoms. Total score ranges from 0 - 48: extreme = 41 - 48, severe = 31 - 40, moderate = 21 - 30, mild = 8 - 20.
Secondary	VAS (gambling craving)	Baseline to Week 3, 6, 9 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 craving of gambling will be assessed.
Secondary	Gambling severity (PGSI)	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 severity of gambling will be assessed.
Secondary	Gambling severity (DSM-5)	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. From baseline to week 6, and 12 severity of gambling will be assessed.
Secondary	Gambling problems (NODS)	Baseline to Week 3, 6, 9 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 level of gambling problems will be assessed.
Secondary	Gambling expenditure and frequency	Baseline to Week 12	daily questionnaire / telephone operated (text messages) diary (daily use of sprays, number of doses, gambling expenditure and frequency and possible adverse events) and self-administration of IMP.
Secondary	Abstinence of gambling (GASS)	Baseline to Week 3, 6, 9 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 3,6,9,and 12 abstinence of gambling will be assessed.
Secondary	Internet use (Internet disorder scale-9 short form)	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 internet use will be assessed.
Secondary	Quality of life (WHO: EUROHIS-8)	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 quality of life will be assessed.
Secondary	Alcohol consumption (AUDIT)	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 graving of gambling will be assessed.
Secondary	Depression (MADRS)	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. From baseline to weeks 6, and 12 mood will be assessed.
Other	Number and proportion of subjects with adverse events	Baseline to week 12 - daily	The use of the daily questionnaire / telephone operated (text messages) diary (daily use of sprays, number of doses, gambling expenditure and frequency and possible adverse events) and self-administration of IMP.
Other	Assessment of clinical laboratory parameters - Pregnancy test	Screening to Week 6 and 12	The entire study for an individual participant will last 12 weeks. At Screening and week 12 blood pregnancy test and week 6 urine pregnancy test
Other	Assessment of vital signs - blood pressure, pulse, temperature	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. Assessments at baseline, 6 and 12 vital signs ( blood pressure, pulse and temperature) will be assessed.
Other	Assessment of body height	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. Assessments at the baseline, week 6, and week 12. Body height will be assessed.
Other	Assessment of body weight	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. Assessment at baseline, 6, and 12 . Body weight will be assessed.
Other	Assessment and examination of nasal mucosa	Baseline to Week 6 and 12	The entire study for an individual participant will last 12 weeks. Assessment at baseline, 6, and 12 nasal mucosa will be assessed using Nasal Irritation Scale (0= normal appearing mucosa, no bleeding to 5= Ulcerated lesions, bleeding with requires medical intervention). Assessment is performed by MD.
Other	Assessment of smell test	Baseline to Week 12	The entire study for an individual participant will last 12 weeks. Assessments at baseline and week 12 smell will be assessed.Smell test will be conducted at Baseline and Week 12. NIH Toolbox Odour Identification Test: This validated smell identification test uses 'scratch and sniff' technology, and pictures for the multiple-choice options of 9 common smells. It is intended for a rapid research assessment of olfactory ability.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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