CBT for Insomnia in Cannabis Users

Overseen By Libby Cardoni

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Steroids

Disqualifiers: Sleep disorders, Psychotic disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two treatments for individuals who use cannabis and experience sleep difficulties. One group will receive cognitive behavioral therapy specifically for insomnia (CBT for Insomnia), while the other will receive education on good sleep habits. The researchers aim to assess how these treatments impact sleep quality, cannabis use, and daytime functioning. Individuals who frequently struggle with sleep, use cannabis at least three times a week, and have a stable living situation may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance sleep and overall well-being.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications known to have started their insomnia. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Cognitive Behavioral Therapy for insomnia (CBTi) is generally safe. Studies indicate that participants who tried CBTi did not experience major negative effects and developed better attitudes towards sleep, demonstrating that CBTi is well-tolerated. Sleep Hygiene Education, the other treatment in this trial, is also safe. It involves learning good sleep habits and does not cause negative side effects. Both treatments have been used safely in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cognitive Behavioral Therapy for insomnia (CBTi) among cannabis users because it is delivered via telemedicine, making it highly accessible for individuals who might not have easy access to in-person therapy. Unlike traditional therapy options that often require face-to-face sessions, this method allows participants to receive treatment in the comfort of their own homes. Additionally, CBTi specifically targets the thoughts and behaviors that contribute to insomnia, offering a focused approach that might be more effective for this group than general sleep aids or medications. By combining this with Sleep Hygiene Education, the trial aims to provide comprehensive support, potentially improving sleep quality without relying on drugs.

What evidence suggests that this trial's treatments could be effective for insomnia in cannabis users?

Research has shown that cognitive behavioral therapy for insomnia (CBTi) can assist people who use cannabis. Studies have found that CBTi improves sleep and reduces insomnia severity. It also appears to alleviate anxiety and depression. In this trial, participants will receive either CBTi-CB-TM, a version of CBTi tailored for cannabis users, or Sleep Hygiene Education. CBTi-CB-TM has shown promise in enhancing sleep and decreasing cannabis use. Both therapies are offered through telemedicine, ensuring easy access and convenience. ^{2 4 5 6 7}

Who Is on the Research Team?

Todd Arnedt, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Adults with mild insomnia and problematic cannabis use, using cannabis for sleep at least three times a week. Must have stable housing, Wi-Fi access, and be able to visit Ann Arbor for assessments. Excludes non-English speakers, those unable to consent, diagnosed with certain mental disorders or on night shifts.

Inclusion Criteria

I have long-term trouble sleeping.

A positive urine drug screen (UDS) for cannabis

Cannabis Use Disorder Identification Test-Revised (CUDIT-R) indicative of at least problematic cannabis use

Exclusion Criteria

I am capable of understanding and consenting to participate.

Self-reported pregnancy

I do not understand English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telemedicine-delivered cognitive behavioral therapy for insomnia or sleep hygiene education

8 weeks

Weekly telemedicine sessions

Follow-up

Participants are monitored for sleep, cannabis use, and daytime functioning

32 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for insomnia
• Sleep Hygiene Education

Trial Overview The trial is testing if cognitive behavioral therapy for insomnia via telemedicine (CBTi-CB-TM) is more effective than just sleep hygiene education (SHE-TM) in improving sleep quality, reducing cannabis use, and enhancing daytime function in adults who use cannabis for sleep.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy for insomnia (CBTi-CB-TM) Experimental Treatment 1 Intervention

Delivered via telemedicine

Group II: Sleep Hygiene Education Active Control 1 Intervention

Delivered via telemedicine

Cognitive Behavioral Therapy for insomnia is already approved in United States, European Union for the following indications:

Approved in United States as CBTi for:

• Insomnia
• Anxiety
• Depression

Approved in European Union as CBTi for:

• Insomnia
• Anxiety
• Depression

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy for insomnia (CBTi) is an effective alternative to medication for treating insomnia, which affects up to 30% of adults, and has been shown to improve various sleep-related outcomes such as sleep onset latency and sleep quality.

CBTi includes techniques like sleep hygiene and cognitive therapy, making it a safe and beneficial option for both adults and adolescents, although access to this therapy can be limited by certain barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. Haynes, J., Talbert, M., Fox, S., et al.[2018]

Internet-based cognitive behavioral therapy for insomnia (I-CBTI) is a highly acceptable treatment option that significantly improves insomnia symptoms for patients who may not have access to traditional CBTI.

The effectiveness of I-CBTI can vary based on specific treatment characteristics and individual patient factors, suggesting that tailoring the approach could enhance outcomes for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2019]

Cognitive Behavioral Therapy for insomnia (CBTi) significantly improved sleep quality in individuals with cannabis use disorder, with participants showing a decrease in insomnia severity from moderately severe to no clinically significant insomnia after treatment, and these improvements were sustained at 3- and 6-month follow-ups.

Additionally, 80% of participants reported reduced cannabis use three months after completing CBTi, and there were trends indicating decreased levels of inflammatory markers (IL-2, IL-6, CRP) six months post-treatment, suggesting potential health benefits beyond sleep improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cognitive behavioral therapy for insomnia in individuals with cannabis use disorder utilizing actigraphy and serum biomarkers: A pilot study. Geagea, L., Ghanimé, PM., El Hayek, S., et al.[2023]

Brief behavioral treatment for insomnia (BBTI) is a 4-session program that can effectively reduce insomnia symptoms, such as difficulty falling asleep and waking up during the night, making it a practical option for non-psychologist health professionals to administer.

BBTI has shown promising results, including cases of full remission from insomnia, and ongoing clinical trials are exploring its efficacy in different treatment settings and delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. Gunn, HE., Tutek, J., Buysse, DJ.[2019]

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

Cognitive Behavioral Therapy for Insomnia (CBTI) is recognized as the first-line treatment for chronic insomnia, supported by strong empirical evidence of its effectiveness, particularly in cases of primary insomnia.

Recent developments in CBTI show promising results for treating insomnia alongside other health conditions, its use as a maintenance therapy, and the potential for delivering CBTI through technology and in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Siebern, AT., Manber, R.[2022]

Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment for chronic insomnia, but many patients opt for medication due to cost and availability issues.

Internet-based CBTI (I-CBTI) is well-accepted by patients and significantly improves insomnia symptoms, suggesting it could be a valuable alternative for those unable to access traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2020]

A web-delivered cognitive behavior therapy for insomnia (CBTI) program significantly reduced anxiety and insomnia symptoms in a study of 22 adults, demonstrating its efficacy as a treatment option.

Participants in the CBTI group experienced greater improvements in sleep onset latency and overall sleep quality compared to those receiving general sleep hygiene information, suggesting that online CBTI can effectively address insomnia and its comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. Pillai, V., Anderson, JR., Cheng, P., et al.[2022]

A randomized controlled trial is evaluating the effectiveness of provider-supported self-help Cognitive Behavioral Therapy for Insomnia (Tele-Self CBTi) in veterans with insomnia, aiming to improve access to treatment for this population with significant sleep difficulties.

If proven effective, Tele-Self CBTi could serve as a crucial entry-level intervention for veterans, potentially addressing the high demand for insomnia treatment and improving overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. Ulmer, CS., Bosworth, HB., Zervakis, J., et al.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) is a safe and effective alternative to sleeping medications, but many patients are unaware or reluctant to engage with it, preferring sedative hypnotics instead.

Focus groups with 29 Veterans revealed that patients prefer a stepped-care approach to CBT-I, starting with self-management tools and progressing to provider-delivered therapy if necessary, highlighting the need for multiple outreach efforts and delivery options to increase engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sign Me Up, I'm Ready!": Helping Patients Prescribed Sleeping Medication Engage with Cognitive Behavioral Therapy for Insomnia (CBT-I). Koffel, E., Branson, M., Amundson, E., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36940598/

Cognitive behavioral therapy for insomnia to reduce cannabis ... Conclusions: CBTi-CB-TM is feasible, acceptable, and demonstrated preliminary efficacy for improving sleep and cannabis-related outcomes among ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36244318/

Assessing cognitive behavioral therapy for insomnia in ... Conclusions: CBTi is effective as a short- and long-term treatment of insomnia and comorbid anxiety/depression in individuals who regularly use cannabis. A ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037687162300073X

Cognitive behavioral therapy for insomnia to reduce ... CBTi-CB-TM is feasible, acceptable, and demonstrated preliminary efficacy for improving sleep and cannabis-related outcomes among non-treatment-seeking ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9796

Cannabis use as a moderator of cognitive behavioral therapy ... This finding indicates that CBT-I is effective in reducing insomnia severity among young adults, regardless of cannabis use during treatment.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05814822

Targeting Insomnia to Improve Outcomes in Adults With ... This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB- ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945722011467

Assessing cognitive behavioral therapy for insomnia in ... Recurrent cannabis users who received CBTi scored higher on the Dysfunctional Beliefs and Attitudes about Sleep (DBAS) scale as compared to healthy adults [5], ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02102230

Study Details | NCT02102230 | CBT-I for Cannabis Use The purpose of this study is to investigate the efficacy of a group-based behavioral sleep intervention, and the incremental benefit provided by an adjunct ...