Clinical trial

Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence

NCT03651869

Name

28IR-0063

Description

This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.

Trial arms

Trial start

2019-02-04

Estimated PCD

2023-03-23

Trial end

2023-03-23

Status

Completed

Phase

Early phase I

Treatment

Cigarette 1

Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)

Arms:

Condition 1, Condition 3

Cigarette 2

Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)

Arms:

Condition 2, Condition 4

Patch 1

A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)

Arms:

Condition 1, Condition 2

Patch 2

A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)

Arms:

Condition 3, Condition 4

Size

221

Primary endpoint

Smoking Urge

Throughout study completion, an average of two weeks.

Eligibility criteria

Inclusion Criteria: * At least 21 years old * Daily smoking at least 2 years Exclusion Criteria: * Currently pregnant or breastfeeding.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 221, 'type': 'ACTUAL'}}

Updated at

2023-07-13

1 organization

4 products

3 indications

Organization

University of Southern California

Product

Cigarette

Indication

Tobacco use disorder

Indication