Cannabis Use DisorderPhase 1NCT06920238
Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use
A Phase 1 study testing Therabot-CALM in people with Cannabis Use Disorder and Anxiety, run by Trustees of Dartmouth College at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Use Disorder, Anxiety, Depression, Anxiety
- What is being tested?
- Therabot-CALM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2025to 28 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is 18 years or older.
- Meet criteria for current CUD (CUDIT-R>=12) and MDD (PHQ-9>=10), and/or GAD (GAD-7>=10).
- Have reliable access to the internet and a compatible device for Therabot-CALM.
- Have willingness and capacity to provide informed consent and commit to participating in all assessments and interventions during the study.
- Attend the first interview.
Who cannot join
- Moderate to High risk of STBs as determined by the C-SSRS or baseline questionnaires.
- Current psychosis (as determined by brief psychosis screen).
- Current participation in another digital mental health intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
46 Centerra Parkway, Suite 300, Office #333S
Lebanon, New Hampshire, 03766
About this study
Official title: A Phase I Single-Arm Trial to Test the Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use Disorder (CUD)
The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. The main question it aims to answer is:
What is the usability, feasibility, and acceptability of Therabot-CALM in persons with Cannabis Use Disorder and Anxiety and/or Depression?
Participants will
- Take a screening questionnaire
- Participate in two virtual 1-hour interviews to provide feedback on app design and suggest features.
- Engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience in a third virtual interview
Read the detailed description
Participants will complete a two-stage screening process via REDCap to determine their eligibility for enrollment. Participants who meet criteria and provide informed consent will be enrolled and participate in three interviews and the 4-week clinical trial.
After the first interview, researchers will fine-tune Therabot-CALM based on feedback received during the interview. After the second interview, experts by experience (EBEs) will engage with Therabot-CALM at least once per day for 4 weeks. After the clinical trial period, participants will receive an email with a link to complete the post-intervention measures delivered via REDCap, including the System Usability Scale (SUS), Treatment Acceptability and Adherence Scale (TAAS), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU), the 9-item Patient Health Questionnaire for depression (PHQ-9), and the 7-item generalized anxiety disorder screener for DSM-5 (GAD-7). Participants will then be asked to return for a third interview to provide feedback on their experience with Therabot-CALM.
Researchers will use the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Impact Framework to plan and conduct three, one-on-one interviews with a trained research assistant (RA). Each interview script will be developed using the IDEAS Impact Framework and follow a semi-structured design, such that the RA will follow a set of questions, with as-needed probing for follow-up. Interviews will be recorded via a virtual platform.
- Conditions
- Cannabis Use Disorder, Anxiety, Depression, Anxiety, Depression - Major Depressive Disorder
- Being tested
- Therabot-CALM
- Keywords
- Artifical Intelligence, Generative AI, Generative Artificial Intelligence, Therabot, Therabot-CALM, Cannabis Use Disorder, Anxiety, Depression, Chatbot, Cannabis Use, Drug Abuse, Drug Use, Drug Use Disorder, Interview, Screening, Application, REDCap, post-intervention measures, System Usability Scale, Treatment Acceptability and Adherence Scale
- Medical subject headings
- Anxiety Disorders, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therabot-CALMDevice
Therabot is a generative-AI-driven mobile app designed to provide mental health treatment. The feasibility of Therabot-CALM, an adapted Therabot application, is being tested for the future use of treating co-occurring substance use disorders and anxiety and/or depression. The primary purpose of this study is application feasibility.
| Study group | Role | What they receive |
|---|---|---|
| Therabot-CALM | Experimental | Participants will engage in three one-hour interviews and a 4-week clinical trial where they may interact with Therabot-CALM as much or as little as they want. Receives: Device: Therabot-CALM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility of the application is measured by engagement rates of participants. Engagement rates will be quantified based on the frequency and duration of interactions with the application during the clinical trial period.
Measured: From enrollment to the end of the third interview at around 10 months
Usability
Usability is measured by participant responses on the System Usability Scale (SUS). The SUS score will range from 0 to 100, where higher scores indicate better usability.
Measured: From enrollment to the end of the third interview at around 10 months
Acceptability
Acceptability is measured by the Treatment Acceptability and Adherence Scale (TAAS), the Likert-style satisfaction rating scale to assess satisfaction with Therabot-CALM. The TAAS scale will range from 0 to 100, where higher scores indicate higher acceptability. The Likert-style satisfaction rating scale will range from 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Measured: From enrollment to the end of the third interview at around 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start13 Apr 2025
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Therabot-CALM Model
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nicholas Jacobson, Trustees of Dartmouth College
- Investigators
- Nicholas C Jacobson, Ph.D., Principal investigator, Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920238
- Sponsor's protocol ID
- STUDY00033219
- Other IDs
- 5P30DA029926-14
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heinz, M. V., Mackin, D., Trudeau, B., Bhattacharya, S., Wang, Y., Banta, H. A., Jewett, A. D., Salzhauer, A., Griffin, T., & Jacobson, N. C. (2024). Evaluating Therabot: A Randomized Control Trial Investigating the Feasibility and Effectiveness of a Generative AI Therapy Chatbot for Depression, Anxiety, and Eating Disorder Symptom Treatment. OSF. https://doi.org/10.31234/osf.io/pjqmr
Collins AC, Bhattacharya S, Oh JY, Salzhauer A, Taylor CT, Wolitzky-Taylor K, Aupperle RL, Budney AJ, Jacobson NC. Inclusion of Individuals With Lived Experiences in the Development of a Digital Intervention for Co-Occurring Depression and Cannabis Use: Mixed Methods Investigation. JMIR Form Res. 2024 Oct 7;8:e54751. doi: 10.2196/54751.
PubMed 39374076
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single-Arm Trial to Test the Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use Disorder (CUD)
- ClinicalTrials.gov ID
- NCT06920238
- Acronym / sponsor ID
- STUDY00033219
- Conditions
- Cannabis Use Disorder, Anxiety, Depression, Anxiety, Depression - Major Depressive Disorder
- Keywords
- Artifical Intelligence, Generative AI, Generative Artificial Intelligence, Therabot, Therabot-CALM, Cannabis Use Disorder, Anxiety, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Apr 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. The main question it aims to answer is:
What is the usability, feasibility, and acceptability of Therabot-CALM in persons with Cannabis Use Disorder and Anxiety and/or Depression?
Participants will
- Take a screening questionnaire
- Participate in two virtual 1-hour interviews to provide feedback on app design and suggest features.
- Engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience in a third virtual interview
Detailed description
Participants will complete a two-stage screening process via REDCap to determine their eligibility for enrollment. Participants who meet criteria and provide informed consent will be enrolled and participate in three interviews and the 4-week clinical trial.
After the first interview, researchers will fine-tune Therabot-CALM based on feedback received during the interview. After the second interview, experts by experience (EBEs) will engage with Therabot-CALM at least once per day for 4 weeks. After the clinical trial period, participants will receive an email with a link to complete the post-intervention measures delivered via REDCap, including the System Usability Scale (SUS), Treatment Acceptability and Adherence Scale (TAAS), Cannabis Use Disorders Identification Test - Revised (CUDIT-R), the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU), the 9-item Patient Health Questionnaire for depression (PHQ-9), and the 7-item generalized anxiety disorder screener for DSM-5 (GAD-7). Participants will then be asked to return for a third interview to provide feedback on their experience with Therabot-CALM.
Researchers will use the IDEAS (Innovate, Develop, Evaluate, Adapt, Scale) Impact Framework to plan and conduct three, one-on-one interviews with a trained research assistant (RA). Each interview script will be developed using the IDEAS Impact Framework and follow a semi-structured design, such that the RA will follow a set of questions, with as-needed probing for follow-up. Interviews will be recorded via a virtual platform.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Therabot-CALM Model
| Arm | Type | Receives |
|---|---|---|
| Therabot-CALM | Experimental | Device: Therabot-CALMParticipants will engage in three one-hour interviews and a 4-week clinical trial where they may interact with Therabot-CALM as much or as little as they want. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is 18 years or older.
- Meet criteria for current CUD (CUDIT-R>=12) and MDD (PHQ-9>=10), and/or GAD (GAD-7>=10).
- Have reliable access to the internet and a compatible device for Therabot-CALM.
- Have willingness and capacity to provide informed consent and commit to participating in all assessments and interventions during the study.
- Attend the first interview.
Key exclusion criteria (3 listed)
- Moderate to High risk of STBs as determined by the C-SSRS or baseline questionnaires.
- Current psychosis (as determined by brief psychosis screen).
- Current participation in another digital mental health intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therabot-CALMTherabot is a generative-AI-driven mobile app designed to provide mental health treatment. The feasibility of Therabot-CALM, an adapted Therabot application, is being tested for the future use of treating co-occurring substance use disorders and anxiety and/or depression. The primary purpose of this study is application feasibility. | Device | Therabot-CALM |
Primary outcome
Feasibility
Time frame: From enrollment to the end of the third interview at around 10 months
Feasibility of the application is measured by engagement rates of participants. Engagement rates will be quantified based on the frequency and duration of interactions with the application during the clinical trial period.
Usability
Time frame: From enrollment to the end of the third interview at around 10 months
Usability is measured by participant responses on the System Usability Scale (SUS). The SUS score will range from 0 to 100, where higher scores indicate better usability.
Acceptability
Time frame: From enrollment to the end of the third interview at around 10 months
Acceptability is measured by the Treatment Acceptability and Adherence Scale (TAAS), the Likert-style satisfaction rating scale to assess satisfaction with Therabot-CALM. The TAAS scale will range from 0 to 100, where higher scores indicate higher acceptability. The Likert-style satisfaction rating scale will range from 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- BackgroundHeinz, M. V., Mackin, D., Trudeau, B., Bhattacharya, S., Wang, Y., Banta, H. A., Jewett, A. D., Salzhauer, A., Griffin, T., & Jacobson, N. C. (2024). Evaluating Therabot: A Randomized Control Trial Investigating the Feasibility and Effectiveness of a Generative AI Therapy Chatbot for Depression, Anxiety, and Eating Disorder Symptom Treatment. OSF. https://doi.org/10.31234/osf.io/pjqmr
- Background: PubMed 39374076Collins AC, Bhattacharya S, Oh JY, Salzhauer A, Taylor CT, Wolitzky-Taylor K, Aupperle RL, Budney AJ, Jacobson NC. Inclusion of Individuals With Lived Experiences in the Development of a Digital Intervention for Co-Occurring Depression and Cannabis Use: Mixed Methods Investigation. JMIR Form Res. 2024 Oct 7;8:e54751. doi: 10.2196/54751.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas C Jacobson, Ph.D. principal investigator
Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Therabot-CALM in people with Cannabis Use Disorder and Anxiety, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From enrollment to the end of the third interview at around 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920238, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.