Intensive Day Monitoring for Cannabis Use

(CLR2 Trial)

Overseen By Ryan Conway

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Psychotropic drugs

Disqualifiers: Major psychiatric disorders, significant medical conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the biological changes associated with heavy cannabis use and determine if these changes can predict increased cannabis cravings, particularly when exposed to cannabis-related triggers or stress. Participants will undergo intensive smartphone monitoring over several weeks to collect data. Ideal candidates are adults who use cannabis at least once a week, do not have other substance use disorders besides mild cannabis and alcohol use, and are not seeking treatment for their cannabis use. As an unphased study, this trial offers participants a unique opportunity to contribute to groundbreaking research on cannabis use and its effects.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use medications that interfere with the hypothalamic-pituitary-adrenal axis response and psychotropic drugs other than antidepressants. If you are on such medications, you may need to stop taking them to participate.

What prior data suggests that Intensive Day Monitoring is safe for cannabis users?

Research on Intensive Day Monitoring for cannabis users lacks specific safety data. This trial involves cannabis users who are not seeking treatment and use cannabis anywhere from once a week to many times a day. It includes smartphone surveys, saliva samples, heart rate checks, and an alcohol use monitor.

Since this trial focuses on observation rather than drug testing, it doesn't follow the usual phase study model, suggesting minimal risks. The trial primarily observes participants' habits and physical responses, so significant safety concerns are unlikely.

However, heavy cannabis use can lead to issues like impaired thinking and other health problems, which relate to cannabis use itself, not the monitoring process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cannabis use, which often involve counseling or medication, Intensive Day Monitoring uses a smartphone-based approach to track usage patterns closely. This method includes frequent smartphone surveys, saliva samples, and heart rate monitoring to provide real-time data on cannabis use. Researchers are excited because this intensive monitoring could offer deeper insights into usage behaviors and triggers, potentially leading to more personalized and effective interventions.

What evidence suggests that Intensive Day Monitoring is effective for cannabis use?

Research has shown that Intensive Day Monitoring, which participants in this trial will undergo, can help individuals with a history of substance use achieve better outcomes. Specifically, studies have demonstrated its effectiveness in improving the daily lives of those with cannabis use. This method involves regular check-ins and monitoring, helping individuals better understand and manage their cravings. Although not a direct treatment, it aims to increase awareness of cannabis use and its triggers, potentially reducing use over time. ^{1 4 6 7 8}

Who Is on the Research Team?

Stephanie Wemm, PhD

Principal Investigator

Associate Research Scientist, Psychiatry

Are You a Good Fit for This Trial?

This trial is for adults over 18 who use cannabis at least once a week and have done so in the past year. They should only have mild Cannabis and Alcohol Use Disorders, if any, be fluent in English, able to consent to the study, and test negative for alcohol but positive for cannabis.

Inclusion Criteria

Cannabis-using men and women who can provide negative alcohol breathalyzer and only positive for cannabis at all visits

I use cannabis and can sign a consent form.

I use cannabis at least once a week.

Exclusion Criteria

Individuals will be excluded if they meet current or past for major psychiatric disorders, other than depression or anxiety disorder

Individuals will be excluded if they meet criteria for a current Substance Use Disorder other than mild Cannabis Use Disorder and Alcohol Use Disorder

I do not have any major health issues that need medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Smartphone Monitoring

Participants complete four weeks of smartphone monitoring, including surveys and saliva sampling

4 weeks

Daily smartphone surveys, saliva samples on three consecutive days

Intensive Monitoring

Participants undergo intensive monitoring with more frequent surveys, saliva samples, heart rate monitoring, and alcohol use monitoring

3 days

Follow-up

Participants are monitored for stress and craving responses after the monitoring period

48 days

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Day Monitoring

Trial Overview

The study is testing 'Intensive Day Monitoring' methods to understand how heavy cannabis use affects the body and whether these changes can predict intense cravings when exposed to stress or reminders of cannabis.

How Is the Trial Designed?

Group I: Individuals who use cannabis Experimental Treatment 1 Intervention

Participants who are non-treatment seeking cannabis users (30 men, 30 women) ranging from once weekly use to multiple times daily. All participants will be recruited from the greater New Haven community and will complete four weeks of smartphone monitoring. During this monitoring period, they will also complete two three-consecutive days of intensive monitoring including more frequent smartphone surveys, saliva samples, heart rate monitoring, and an alcohol use monitor.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Robert E. Leet and Clara Guthrie Patterson Trust Mentored Research Award

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

The computerized system for monitoring adverse drug reactions (ADRs) at a university hospital has effectively reported 340 ADRs in its first nine months, allowing for rapid detection and evaluation of these reactions.

The program enables targeted educational initiatives for hospital staff based on identified ADR trends, enhancing patient safety and improving the overall quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a database computer program to identify trends in reporting of adverse drug reactions. Johnston, PE., Morrow, JD., Branch, RA.[2013]

Daytime intensive monitoring, conducted over 6 to 8 hours, successfully answered 67% of clinical questions from referring physicians and recorded 55% of attacks in a study of 166 cases.

This approach is shown to be a useful and cost-effective alternative to longer inpatient monitoring and traditional ambulatory monitoring methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daytime intensive monitoring: comparison with prolonged intensive and ambulatory monitoring. Rowan, AJ., Siegel, M., Rosenbaum, DH.[2019]

A comprehensive survey of all 85 Dutch institutions offering partial hospitalization revealed that they provide 1914 treatment places for 2995 patients weekly, indicating a robust system for mental health care in the Netherlands.

The Dutch model of partial hospitalization serves primarily as an alternative to outpatient treatment and as a continuation of inpatient care, but the full potential of these programs as alternatives to inpatient treatment has not yet been realized.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and current status of partial hospitalization in The Netherlands. Schene, A., van Lieshout, P., Mastboom, J.[2018]

The implementation of a hospital-based intensive day care program for alcoholics significantly reduced drop-out rates compared to conventional outpatient counseling, indicating better patient retention.

In this program, 41.6% of patients experienced significant short-term improvement, suggesting that intensive day care is an effective and low-cost treatment option for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hospital day care program for alcoholics. Collins, GB., Watson, EW., Zrimec, GL.[2019]

The day-treatment program aims to prevent severely disturbed older adolescents from becoming chronically ill young adults, focusing on improving their educational and social outcomes.

Clinical vignettes demonstrate the program's effectiveness in helping patients with histories of hospitalization and substance abuse achieve better educational achievements and enhanced social functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A bridge over troubled waters: an innovative day-treatment program for older adolescents. Byalin, K., Smith, A., Chatkin, M., et al.[2015]

Prescription Drug Monitoring Programs (PDMP) are being used to improve clinical care and harm reduction by tracking the prescribing of controlled substances, helping to identify prescription dependence and ensure appropriate medication supply.

Despite their benefits, PDMPs can also lead to negative consequences such as increased stigma, untreated pain, and denial of care for patients labeled as 'high risk', highlighting the need for further research to understand their impact on affected populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Key considerations for the implementation of clinically focused Prescription Drug Monitoring Programs to avoid unintended consequences. Haines, S., Savic, M., Nielsen, S., et al.[2022]

Patients and their families expressed hope that the Prescription Drug Monitoring Programs (PDMP) would reduce the misuse of medications, but they also voiced significant concerns about managing withdrawal and stress without these medications.

The study highlighted that while PDMPs can help monitor prescription use, they may also lead to stigma and strained relationships between patients and healthcare providers, suggesting a need for better communication and awareness of biases in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient experiences of prescription drug monitoring programs: a qualitative analysis from an Australian pharmaceutical helpline. Haines, S., Lam, A., Savic, M., et al.[2022]

Intensive outpatient programs (IOPs) for substance use disorders are highly effective, showing comparable outcomes to inpatient treatment based on a review of 12 studies and one review published between 1995 and 2012.

All studies indicated reductions in alcohol and drug use among participants, highlighting the efficacy of IOPs, but there was significant variability in how these programs were implemented and measured, suggesting a need for standardization to enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance abuse intensive outpatient programs: assessing the evidence. McCarty, D., Braude, L., Lyman, DR., et al.[2021]

In a study of 1280 adult patients over 12 months, 5.2% experienced adverse drug reactions (ADRs), with 3.9% leading to hospitalizations and 1.3% occurring during hospitalization, highlighting the prevalence of ADRs in medical settings.

Most ADRs were preventable (62.7%), with nonsteroidal anti-inflammatory drugs and antidiabetics being the most implicated, leading to significant morbidity and mortality, including a 10.4% fatality rate among affected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cohort study on adverse drug reactions in adults admitted to the medical wards of a tertiary hospital in Nigeria: Prevalence, incidence, risk factors and fatality. Adedapo, ADA., Adedeji, WA., Adedapo, IA., et al.[2021]

In a study of 229 new admissions to a psychiatric treatment program, 34% were diagnosed with drug dependence/abuse, but a much higher 69% were identified as misusing drugs through a research protocol, highlighting a significant gap in diagnosis.

Drug misuse identified by the research protocol was a strong predictor of early exit from treatment (relative risk = 2.7), suggesting that incorporating drug misuse assessments could improve treatment outcomes in psychiatric programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undiagnosed Drug Misuse among Admissions to Psychiatric Day Treatment and Prediction of Early Exit. Magura, S., Spybrook, J., Rosenblum, A., et al.[2021]

The 'Intensive Drug Monitoring' System developed at the Medical College Hannover collects therapy data, clinical symptoms, and chemical parameters to identify potential drug side effects, enhancing patient safety.

This monitoring approach is crucial for addressing specific questions about drug efficacy and safety, and it complements the need for 'Spontaneous Monitoring' of adverse drug effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic collection of drug side effects]. May, B.[2015]

In a study involving 127 homeless individuals with substance use disorders, those receiving day treatment plus contingency management (DT+) were 2.1 times more likely to achieve positive treatment outcomes compared to those receiving only day treatment (DT).

The findings suggest that using diagnostic changes alongside traditional measures like drug toxicology and self-reports can enhance the assessment of treatment effectiveness in substance use disorder interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic compared with abstinence outcomes of day treatment and contingency management among cocaine-dependent homeless persons. Schumacher, JE., Milby, JB., Wallace, D., et al.[2022]

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