NCT03651869

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

4.1 years

First QC Date

August 23, 2018

Last Update Submit

July 11, 2023

Conditions

Smoking, TobaccoSmoking (Tobacco) Addiction

Keywords

Smoking

Outcome Measures

Primary Outcomes (1)

  • Smoking Urge

    Smoking urge is measured using questionnaires that ask about a desire to smoke.

    Throughout study completion, an average of two weeks.

Study Arms (4)

Condition 1

EXPERIMENTAL
Drug: Cigarette 1Drug: Patch 1

Condition 2

EXPERIMENTAL
Drug: Cigarette 2Drug: Patch 1

Condition 3

EXPERIMENTAL
Drug: Cigarette 1Drug: Patch 2

Condition 4

EXPERIMENTAL
Drug: Cigarette 2Drug: Patch 2

Interventions

Cigarette 1DRUG

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

Condition 1Condition 3
Cigarette 2DRUG

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

Condition 2Condition 4
Patch 1DRUG

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

Condition 1Condition 2
Patch 2DRUG

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

Condition 3Condition 4

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 21 years old
  • Daily smoking at least 2 years

You may not qualify if:

  • Currently pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Tobacco SmokingSmokingBehavior, Addictive

Interventions

Sugp2 protein, mouse

Condition Hierarchy (Ancestors)

BehaviorTobacco UseCompulsive BehaviorImpulsive Behavior

Study Officials

  • Adam M Leventhal, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Preventive Medicine and Psychology, Director of the Health, Emotion, and Addiction Laboratory

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 29, 2018

Study Start

February 4, 2019

Primary Completion

March 23, 2023

Study Completion

March 23, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)