The Impact of Standardized Tobacco Product Packaging on Young Adults in the Retail Environment

• Sponsor: RAND (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05973981
• Collaborator: (none)
• Enrollment: 900
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 47.9
• Patients Per Site Per Month: 18.8

Study Details

Study Description

Brief Summary

The overall aim of this research is to experimentally evaluate the extent to which partially standardizing the color of tobacco packaging influences tobacco use intentions among young adults who have varying levels of tobacco use experience.

Condition or Disease	Intervention/Treatment	Phase
Smoking, Cigarette	Behavioral: Package standardization	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 900 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Impact of Standardized Tobacco Product Packaging on Young Adults in the Retail Environment
• Actual Study Start Date: May 4, 2022
• Anticipated Primary Completion Date: Apr 30, 2026
• Anticipated Study Completion Date: Apr 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Status Quo Packages Cigarette packages appear as they normally do - no standardization	Behavioral: Package standardization; Conditions vary in terms of amount of cigarette packages that are subject to standardization
Experimental: Partial standardization Cigarette packages appear with half of the package using a standardized color	Behavioral: Package standardization; Conditions vary in terms of amount of cigarette packages that are subject to standardization
Experimental: Full standardization Cigarette packages appear with all of the packages fully standardized (by color and font)	Behavioral: Package standardization; Conditions vary in terms of amount of cigarette packages that are subject to standardization

Outcome Measures

Primary Outcome Measures

1. Quit smoking motivation [Immediately after shopping in the RAND StoreLab]

   Motivation to quit smoking as assessed by the Motivation to Stop Scale (MTSS; Kotz et al., 2013; Drug and Alcohol Dependence) participants endorsing one of 7 items: I don't want to stop smoking. I think I should stop smoking but don't really want to. I want to stop smoking but haven't thought about when. I REALLY want to stop smoking but I don't know when I will. I want to stop smoking and hope to soon. I REALLY want to stop smoking and intend to in the next 3 months. I REALLY want to stop smoking and intend to in the next month.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 29 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Ages 21-29

• Past month cigarette smoker

Exclusion Criteria:

• None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	RAND Corporation	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• RAND

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RAND
• ClinicalTrials.gov Identifier: NCT05973981
• Other Study ID Numbers: R01CA261639
• First Posted: Aug 3, 2023
• Last Update Posted: Aug 3, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 3, 2023