CBT for Insomnia in Cannabis Users

Overseen by Todd Arnedt, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Must not be taking: Steroids

Disqualifiers: Sleep disorders, Psychotic disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.

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.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBTi) in cannabis users?

CBTi is effective in improving insomnia symptoms and is generally acceptable to patients, as shown in studies where it was delivered over the Internet. Additionally, a pilot study specifically assessed CBTi in individuals with cannabis use disorder, suggesting its potential benefits in this group. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBTi) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBTi) is considered a safe treatment for insomnia, as it does not involve medication and avoids the risks associated with sleeping pills. It is recommended by health authorities as a standard treatment due to its safety and effectiveness. ^{6 7 8 9 10}

How is CBT for Insomnia in Cannabis Users different from other treatments for insomnia?

CBT for Insomnia (CBTi) is unique because it focuses on changing behaviors and thoughts related to sleep, rather than using medication, making it a safer option with fewer side effects. It includes techniques like sleep hygiene education, stimulus control, and relaxation training, and is recognized as the first-line treatment for chronic insomnia, even when other conditions like cannabis use disorder are present. ^{1 2 3 8 9}

Research Team

Todd Arnedt, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

Self-reported use of cannabis to manage insomnia at least three times weekly for the past month

Exclusion Criteria

I am capable of understanding and consenting to participate.

Self-reported pregnancy

I do not understand English.

Trial Timeline

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

Treatment Details

Interventions

• Cognitive Behavioral Therapy for insomnia (Behavioral Intervention)
• Sleep Hygiene Education (Behavioral Intervention)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

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]

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 (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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2019]

3. Netherlands 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Brief Behavioral Treatment of Insomnia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. [2018]

7. England 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). [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy in the Treatment of Insomnia. [2018]

9. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in cognitive behavioral therapy as the first-line treatment of insomnia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. [2022]