Computerized Intervention for Cannabis Use Disorder

(DISC Trial)

Recruiting at 1 trial location

Overseen By Zoe Howell Project Coordinator, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Must not be taking: Psychotropics

Disqualifiers: Psychiatric disturbance, Pregnancy, Kidney disease, others

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new computerized program called the Emotional Engagement Distress Tolerance Intervention, designed to assist individuals struggling with heavy cannabis use and distress intolerance. The program aims to reduce stress-related cannabis use by teaching coping skills in a single session, with follow-up reminders sent to participants' smartphones. Participants will be randomly assigned to either this new intervention or a health education program, and researchers will closely monitor their progress in managing stress and cannabis use. The trial seeks individuals who use cannabis almost daily, have a diagnosis of Cannabis Use Disorder, and find stress difficult to manage. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to new methods for managing stress and cannabis use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have changed your psychotropic medication (medications affecting mood, perception, or behavior) within the past month.

What prior data suggests that this computerized intervention is safe for cannabis users with CUD?

Research has shown that improving how well people handle uncomfortable emotions or physical sensations can help treat substance use disorders. The Emotional Engagement Distress Tolerance Intervention is a new method being tested for individuals with Cannabis Use Disorder (CUD) who struggle with distress.

This intervention consists of a single session lasting two and a half hours, delivered via computer. It includes video lessons, practicing coping skills, and experiencing emotions. Participants also receive smartphone reminders to reinforce what they learned. Although detailed safety data for this specific intervention is not available, its focus on mental and emotional support suggests a low risk of physical side effects. Generally, these types of interventions are well-tolerated since they don't involve medication. However, individual reactions to emotional content can vary, as with any mental health program.

Overall, despite the absence of specific safety data, the non-invasive nature of this computer-based intervention suggests it is likely safe and well-tolerated for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Emotional Engagement Distress Tolerance Intervention for cannabis use disorder because it offers a unique approach by combining psychoeducation, adaptive skill practice, and emotional exposure in a single 2.5-hour computerized session. Unlike traditional treatments that might rely on behavioral therapy or medication, this intervention uses real-time feedback of skin conductance levels to help participants manage their emotional responses. This innovative method could provide individuals with practical tools for coping with distress, potentially making it a promising option for those seeking help with cannabis use.

What evidence suggests that the Emotional Engagement Distress Tolerance Intervention is effective for Cannabis Use Disorder?

Research has shown that learning to handle emotional or physical discomfort, known as distress tolerance, can help individuals with substance use issues, such as cannabis use disorder (CUD). Studies have found that individuals with low distress tolerance are more likely to use cannabis to cope with negative feelings. In this trial, participants may receive the Emotional Engagement Distress Tolerance Intervention, a computer-based program designed to improve distress tolerance. This intervention has been shown to reduce both the frequency of cannabis use and the reasons for using it to cope with stress. By helping individuals manage discomfort, this approach could lead to better outcomes in cannabis use and overall well-being. ^{1 2 3 5 6}

Who Is on the Research Team?

Richard J Macatee, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for regular cannabis users who have been diagnosed with Cannabis Use Disorder (CUD). Participants should use cannabis nearly every day, test positive for THC, and primarily abuse cannabis over other substances. They must also show high levels of distress intolerance and own a smartphone.

Inclusion Criteria

You have been diagnosed with a current Cannabis Use Disorder.

You have been using cannabis at least once a day for the past month and three months.

A positive result for tetrahydrocannabinol was found in your urine sample.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a single 2.5-hour session of either the Emotional Engagement Distress Tolerance Intervention or the Health Education Intervention, with therapy reminders delivered via smartphone.

1 session

1 visit (in-person)

Follow-up

Participants are monitored for changes in cannabis use, distress intolerance, and psychosocial functioning through various assessments.

4 months

Multiple assessments (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Emotional Engagement Distress Tolerance Intervention

Trial Overview The study tests a one-session computerized intervention designed to help manage stress in people with CUD. It includes smart phone reminders and compares it against a health education program. The goal is to see if this approach can reduce the urge to use cannabis when stressed.

How Is the Trial Designed?

Group I: Emotional Engagement Distress Tolerance Intervention Experimental Treatment 1 Intervention

The experimental intervention (single 2.5 hour session) is comprised of video-delivered psychoeducation, adaptive skill practice, and emotional exposure. During exposure, a sequence of percussive sounds accompanied by a visual depiction of the participant's skin conductance level during exposure will be presented at the moment the participant's skin conductance returns to the relaxation baseline value. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.

Group II: Health Education Intervention Placebo Group 1 Intervention

The health education control intervention is a single 2.5 hour computerized session. It is comprised of audio-narrated videos on healthy habits and self-care in the domains of sleep, nutrition, hygiene, and physical exercise. The same sequence of percussive sounds used in the Emotional Engagement Distress Tolerance Intervention is presented alongside summary slides presenting key points on healthy habits and self-care. These images/sound will be intermittently sent to the participant's smart phone during the smart phone portion of the intervention.

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a study of 63 frequent cannabis users aged 18-21, negative affect (NA) cues led to increased sadness and decreased relaxation, but did not significantly increase cannabis craving after exposure.

The study found that females and individuals with low distress tolerance (DT) experienced greater sadness in response to NA cues compared to males and those with high DT, highlighting the role of sex and DT in emotional reactivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distress tolerance and reactivity to negative affective cues in naturalistic environments of cannabis-using emerging adults. Gex, KS., Gray, KM., McRae-Clark, AL., et al.[2023]

A combination of motivational enhancement therapy (MET), cognitive-behavioral therapy (CBT), and contingency management (CM) is effective for treating cannabis use disorders, and a computer-assisted version of this treatment shows promise in overcoming barriers to access.

In a 12-week study with 38 adults, both therapist-delivered and computer-delivered treatments resulted in similar attendance and cannabis use outcomes, indicating that computer-assisted therapy is a viable alternative that maintains treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. Budney, AJ., Fearer, S., Walker, DD., et al.[2021]

In a study of 203 current cannabis users, perceived distress tolerance was found to significantly predict cannabis use problems, withdrawal severity, and self-efficacy for quitting, highlighting its importance in understanding cannabis-related issues.

Pain-related affective distress was identified as a key mechanism linking perceived distress tolerance to these cannabis use problems, suggesting that addressing pain may help improve outcomes for individuals struggling with cannabis use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between perceived distress tolerance and cannabis use problems, cannabis withdrawal symptoms, and self-efficacy for quitting cannabis: The explanatory role of pain-related affective distress. Manning, K., Rogers, AH., Bakhshaie, J., et al.[2019]

Computer-based interventions for drug use disorders have shown high acceptability and can lead to reduced substance use, increased motivation to change, and better retention compared to traditional treatment methods, based on a review of 12 studies.

These interventions offer a promising alternative due to their lower cost and greater accessibility, suggesting they could significantly transform treatment approaches for drug use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based interventions for drug use disorders: a systematic review. Moore, BA., Fazzino, T., Garnet, B., et al.[2022]

A randomized controlled trial involving 60 cannabis users with high distress intolerance showed that a Distress Tolerance Intervention (DTI) led to greater reductions in cannabis use frequency compared to a healthy habits control intervention.

Both interventions resulted in significant reductions in distress intolerance and cannabis use outcomes, suggesting that while the DTI may be beneficial, its effects were largely similar to the control condition, indicating it could serve as an additional support rather than a standalone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a computerized intervention for high distress intolerance on cannabis use outcomes: A randomized controlled trial. Macatee, RJ., Albanese, BJ., Okey, SA., et al.[2022]

Cannabis Use Disorder (CUD) is on the rise, and there are currently no FDA-approved medications for its treatment, highlighting a significant gap in available resources for prevention and care.

Ecological momentary assessments (EMA) and technology-based interventions, including digital therapeutics and telehealth, show promise in improving the prevention, screening, and treatment of CUD, especially in light of increased acceptance following the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of technology in the assessment and treatment of cannabis use disorder. Brezing, CA., Levin, FR.[2022]

In a study of 103 cannabis-dependent veterans, those with higher perceived distress tolerance were less likely to use cannabis after attempting to quit, indicating that how veterans view their ability to handle distress plays a significant role in their success in quitting.

Interestingly, performance on a laboratory task measuring distress tolerance did not correlate with cannabis use, suggesting that self-perception of distress tolerance may be more important than actual performance in predicting post-quit cannabis use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prospective effects of perceived and laboratory indices of distress tolerance on cannabis use following a self-guided quit attempt. Hasan, NS., Babson, KA., Banducci, AN., et al.[2018]

The study introduces a digital health intervention called iCOPE, designed to enhance engagement and adherence to buprenorphine treatment for Opioid Use Disorder, which is crucial since nearly half of participants struggle to stabilize on this medication.

iCOPE aims to improve treatment outcomes by incorporating personalized feedback and distress tolerance skills training, potentially leading to increased abstinence and retention in treatment, and will be compared to standard treatment methods to assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an integrated digital health intervention to promote engagement in and adherence to medication for opioid use disorder. Langdon, KJ., Ramsey, S., Scherzer, C., et al.[2021]

In a study of 126 current cannabis users, low distress tolerance was linked to increased negative affect and greater cravings for cannabis during a distress-inducing task, highlighting its role as a vulnerability factor for cannabis use.

The findings suggest that individuals with lower distress tolerance may be more likely to experience cravings for cannabis when they are feeling distressed, indicating a potential target for interventions aimed at reducing cannabis use and preventing relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distress tolerance and cannabis craving: The impact of laboratory-induced distress. Buckner, JD., Walukevich Dienst, K., Zvolensky, MJ.[2020]

Undergraduate cannabis users who feel distressed about their cannabis-related problems are more motivated to change their usage and benefit more from personalized feedback interventions (PFIs).

In a study with 204 participants, those with high problem distress who received a PFI showed a greater reduction in cannabis-related problems compared to those who only received personalized normative feedback, highlighting the importance of addressing distress in treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online personalized feedback intervention reduces cannabis-related problems among college students with high problem distress. Walukevich-Dienst, K., Lewis, EM., Neighbors, C., et al.[2021]

Buprenorphine is an effective long-acting treatment for opioid dependence, but many patients experience lapses within the first week due to withdrawal and emotional distress.

A preliminary pilot study involving 5 participants tested a novel distress tolerance treatment, showing it to be feasible and acceptable, and a larger randomized controlled trial is underway to evaluate its effectiveness in enhancing buprenorphine treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of a distress tolerance treatment for opiate-dependent patients initiating buprenorphine: rationale, methodology, and outcomes. Brown, RA., Bloom, EL., Hecht, J., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10681967

Project Details This study aims to evaluate the effect of a one-session computerized distress tolerance intervention with just-in-time text message support.

2. withpower.com withpower.com/trial/phase-1-marijuana-abuse-2-2024-b2348

Computerized Intervention for Cannabis Use Disorder Research shows that targeting distress tolerance, which is the ability to handle emotional or physical discomfort, can improve outcomes in substance use ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7770335/

Impact of a computerized intervention for high distress ... To test the intervention's effect on more distal, CUD-related outcomes, we assessed cannabis use frequency, coping motives for cannabis use, and cannabis use– ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460324000327

Indirect effects of emotion regulation in the relationship ... Individuals with low distress tolerance are more likely to respond to negative affect through efforts to relieve this distress, including substance use and ...

5. mdpi.com mdpi.com/2076-3425/14/3/227

Treatments for Cannabis Use Disorder across the Lifespan One clinical trial found significant improvements in cannabis abstinence rates in young adults with cannabis use disorders. Mason et al. (2018) ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70084

Effectiveness and safety of psychosocial interventions for ... Aim To evaluate the effectiveness, safety and cost-effectiveness of psychosocial interventions for cannabis use disorder (CUD).