Evaluating the Impact of Psychotherapeutic Advertising Claims on Cannabis Purchasing

NCT07216911 | Not Yet Recruiting

• 2 other identifiers: STUDY00033263R21DA062816
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

In the U.S., legal cannabis is frequently advertised as an effective treatment for mental health problems such as anxiety and depression-particularly online. States that have legalized cannabis have not implemented regulations to address this type of advertising. This project aims to investigate the influence of psychotherapeutic advertising claims (PAC) and mental health warning labels (WL) on online cannabis purchasing behaviors among light-to-moderate cannabis users with symptoms of depression and/or anxiety. The specific aims are to determine whether PAC increases cannabis purchasing intentions and whether a mental health WL can mitigate this effect. A realistic online cannabis shopping experience will be simulated using the digital Platform for Online Evaluation of Marijuana Marketing and Sales (POEMMS). The study will employ a between-subjects experimental design by randomizing 2,000 participants to one of four online stores that vary in PAC and WL content: (1) a control claims (CC)-only store, (2) a PAC store, (3) a WL store, and (4) a PAC + WL store. Participants will browse and select items as if making real purchases. Analyses will examine three primary outcomes to determine the influence of PAC and WL on purchasing behaviors: (1) total milligrams of THC purchased, (2) average potency (%THC) of products, and (3) overall number of products purchased. The long-term objective is to inform evidence-based cannabis policy and regulatory strategies by understanding the impact of cannabis marketing on vulnerable populations. This research is relevant to public health by addressing the potential risks associated with misleading cannabis marketing, which may lead to increased use and exacerbation of mental health symptoms among individuals with depression and anxiety. The project leverages a multidisciplinary team with expertise in addiction, mental health, epidemiology, and digital health technology. The findings have the potential to inform the development of targeted interventions and policies to reduce harms associated with cannabis advertising-ultimately contributing to better health outcomes and more effective regulation.

Conditions

Anxiety; Depression; Cannabis Use

Outcome Measures

Primary Outcomes (3)

• Milligrams of THC Purchased

  This outcome measures the cumulative amount of Δ⁹-tetrahydrocannabinol (THC) that participants select during their shopping session in the simulated online cannabis store. THC is the primary psychoactive compound in cannabis, and its quantity is a critical factor in understanding purchasing behavior. Rationale: Measuring total mgTHC allows us to assess whether exposure to PAC or WL influences the overall amount of THC that participants intend to consume. This is important because higher THC consumption is associated with an increased risk of adverse mental health effects. Data Collection: During the shopping task, each cannabis product will list its THC content. The total THC purchased will be calculated by taking the weight of each product purchased and multiplying it by the product's THC potency. The total mgTHC purchased will be the sum of these calculations for all products in the participant's cart.

  Assessed once immediately after completion of the simulated shopping task (cross-sectional, baseline assessment only)

• Average potency (%THC) of products purchased

  This outcome measures the average THC potency of cannabis products selected by participants during the simulated shopping task. THC potency is expressed as a percentage of the product's total weight. Rationale: The average potency of purchased products provides insight into participants' preferences for higher versus lower potency cannabis. This measure is important for understanding the potential influence of PAC, which may encourage selection of higher potency products by implying stronger psychotherapeutic effects. Conversely, WL may reduce the selection of high-potency products by emphasizing the risks associated with elevated THC levels. Data Collection: The average THC potency will be calculated by summing the THC percentages of all products purchased and dividing this total by the number of products purchased.

  Assessed once immediately after completion of the simulated shopping task (cross-sectional, baseline assessment only)

• Overall number of products purchased

  This outcome measures the total number of cannabis products that participants add to their cart during the simulated shopping task. Rationale: The number of products purchased serves as an indicator of purchasing behavior and preference for product variety. This measure helps assess whether participants exposed to PAC are more likely to purchase a greater number of different products, potentially due to claims about diverse effects or benefits. Similarly, it helps to understand if WL reduces the number of products purchased by making participants more cautious. Data Collection: The total number of products purchased will be recorded directly from each participant's shopping cart at the end of the shopping task.

  Assessed once immediately after completion of the simulated shopping task (cross-sectional, baseline assessment only)

Study Arms (4)

Control Claims (CC) Store

ACTIVE COMPARATOR

The Control Claims (CC) store only includes claims about neutral product attributes (e.g., activation time and batch number).

Behavioral: CC

PAC Store

EXPERIMENTAL

The PAC Store includes CC plus claims about a product's mental health effects (e.g., 'Calming') and symptom relief (e.g., 'Helps with: Stress').

Behavioral: CC; Behavioral: PAC

WL Store

EXPERIMENTAL

The WL Store includes CC plus a WL about the negative impact of THC on anxiety and depression.

Behavioral: CC; Behavioral: WL

PAC + WL Store

EXPERIMENTAL

The PAC+WL Store includes PACs, WL, and CC.

Behavioral: CC; Behavioral: PAC; Behavioral: WL

Interventions

CC BEHAVIORAL

Participants are exposed to an online cannabis store condition that includes claims about neutral product attributes.

Control Claims (CC) Store; PAC + WL Store; PAC Store; WL Store

PAC BEHAVIORAL

Participants are exposed to an online cannabis store condition that includes CC plus claims about each product's effects on mental health (e.g., "Calming") and symptom relief (e.g., "Helps with: Stress").

PAC + WL Store; PAC Store

WL BEHAVIORAL

Includes CC plus a mental health warning label about the negative impact of THC on anxiety and depression.

PAC + WL Store; WL Store

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 years or older
• Current residence in the United States
• Cannabis use on 1-100 days in the past year
• Current symptoms of mild to severe depression and/or generalized anxiety disorder, assessed by PHQ-8 (score ≥ 5) and GAD-7 (score ≥ 5)

You may not qualify if:

• Under 21 years of age
• Not currently residing in the United States

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Technology and Behavioral Health (CTBH), Geisel School of Medicine at Dartmouth College

Lebanon, New Hampshire, 03766, United States

Location

Related Links

• NIH RePORTER link for the award

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jennifer Emond, PHD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

• James Sargent, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Alan Budney, PHD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob T Borodovsky, PHD

CONTACT

603-646-7004; Jacob.T.Borodovsky@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: October 15, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified data and accompanying documentation will be made available after publication of each corresponding peer-reviewed paper and no later than the end of the project performance period. All cleaned and de-identified data will remain accessible indefinitely within The National Addiction \& HIV Data Archive Program (NAHDAP). Thus, IPD sharing begins at the time of first publication and continues without an end date.
• Access Criteria: Researchers seeking access to the de-identified IPD must submit a formal data access request to the The National Addiction \& HIV Data Archive Program (NAHDAP). Access will be limited to qualified investigators with institutional approval and a signed data use agreement. The NAHDAP will review all requests to ensure compliance with ethical and confidentiality standards. Approved users will receive controlled access to the requested data, metadata, and analysis code through the NAHDAP secure repository.

Locations

US (1)