|May 17, 2019
|May 28, 2019
|April 21, 2020
|February 10, 2020
|December 2021 (Final data collection date for primary outcome measure)
|Change from baseline Insomnia Severity Index score at study completion [ Time Frame: 12 Weeks ]
The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the patient's perception of both nocturnal and diurnal symptoms of insomnia.
The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem.
|Same as current
|Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
|Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
|As medical cannabis use becomes more common in the United States, it is essential to understand the ways in which adults who use medical cannabis perceive the benefits of cannabis use and to identify effective strategies to help them cope with these problems. Emerging data indicate that insomnia and/or use of cannabis for sleep are very common in medical cannabis patients. The present study will adapt and gather pilot data on the impact of a Cognitive Behavioral Therapy for insomnia (CBTi-CB) intervention on sleep- and cannabis-related outcomes in adults who use medical cannabis.
|In recent years, the movement to promote the legalization of medical cannabis has grown in the United States and now 29 States and the District of Columbia have provisions that allow for the use of cannabis for medical reasons. Irrespective of the specific reasons for seeking medical cannabis, adults who have been evaluated for medical cannabis certification report significant sleep-related problems as well as frequent use of cannabis to address their sleep problems. Cannabis use for sleep is a key potential target for interventions given that prior research has found that, among individuals with cannabis use disorders, poor sleep is a barrier to sustained remission from cannabis use. Cognitive Behavioral Therapy (CBT) for insomnia is highly effective in individuals with insomnia comorbid with other health conditions, including substance use disorders; however, existing efficacy trials have not specifically evaluated its benefit in those who use cannabis for insomnia. The impact of CBT for insomnia on either sleep or cannabis use in medical cannabis users is, therefore, unknown. The objectives of this project are to adapt and tailor a telephone-delivered CBT for insomnia for adults who use medical cannabis (CBTi-CB) and to evaluate the acceptability and feasibility of this intervention. Qualitative and quantitative data will be collected to refine an existing CBTi-CB protocol and conduct a pilot test of the modified intervention in adults who use medical cannabis. Adults seeking certification for medical cannabis will be approached while waiting for their appointment and screened for insomnia as well as cannabis use for sleep. After initial qualitative interviews and beta testing, eligible participants (N = 60) will be randomized to CBTi-CB or Sleep Education Control (SE) condition, delivered over the telephone. Participants will provide self-report data on sleep/insomnia, functioning and cannabis use and objective data on sleep quality will be measured by actigraphy. The study will evaluate changes in self-reported and objectively measured sleep, functioning and frequency/quantity of cannabis use during treatment and over the course of 18-weeks post-baseline. Completion of the study aims will provide all of the elements required for a future fully-powered randomized trial of the longer-term efficacy of CBTi-CB among those with medical cannabis. This line of research would be the first to evaluate a highly effective sleep-focused intervention and determine the effects on sleep-related and non-sleep-related cannabis use in a non-treatment seeking population.
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
- Insomnia Chronic
- Cannabis Use
- Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users
Each CBTi-CB therapy session will review the previous week of sleep/wake diaries and summarize key sleep parameters with participants. The treatment will address cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences. The content includes: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
Other Name: Cognitive Behavioral Therapy
- Behavioral: Sleep Education
The SE condition will be matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations. The current content includes: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements.
- Experimental: CBTi-CB
Cognitive Behavioral Therapy for Insomnia in Cannabis Users
Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia in Cannabis Users
- Placebo Comparator: Sleep Education
Psycho-education on sleep and sleep hygiene
Intervention: Behavioral: Sleep Education
- Brook JS, Stimmel MA, Zhang C, Brook DW. The association between earlier marijuana use and subsequent academic achievement and health problems: a longitudinal study. Am J Addict. 2008 Mar-Apr;17(2):155-60. doi: 10.1080/10550490701860930.
- Buckner JD, Heimberg RG, Schmidt NB. Social anxiety and marijuana-related problems: the role of social avoidance. Addict Behav. 2011 Jan-Feb;36(1-2):129-32. doi: 10.1016/j.addbeh.2010.08.015. Epub 2010 Aug 25.
- Substance Abuse and Mental Health Services Administration. Results from the 2009 National Survey on Drug Use and Health: National findings. Vol HHS Publication No. SMA 10-4856Findings. Rockville, MD.: Office of Applied Studies; 2010.
- Moore BA, Augustson EM, Moser RP, Budney AJ. Respiratory effects of marijuana and tobacco use in a U.S. sample. J Gen Intern Med. 2005 Jan;20(1):33-7.
- D'Souza DC. Cannabinoids and psychosis. Int Rev Neurobiol. 2007;78:289-326. Review.
- Gruber AJ, Pope HG, Hudson JI, Yurgelun-Todd D. Attributes of long-term heavy cannabis users: a case-control study. Psychol Med. 2003 Nov;33(8):1415-22.
- Hasin DS, Saha TD, Kerridge BT, Goldstein RB, Chou SP, Zhang H, Jung J, Pickering RP, Ruan WJ, Smith SM, Huang B, Grant BF. Prevalence of Marijuana Use Disorders in the United States Between 2001-2002 and 2012-2013. JAMA Psychiatry. 2015 Dec;72(12):1235-42. doi: 10.1001/jamapsychiatry.2015.1858.
- Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80.
- Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89.
- Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11.
- Morin CM, Vallières A, Guay B, Ivers H, Savard J, Mérette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.
- Buysse DJ, Germain A, Moul DE, Franzen PL, Brar LK, Fletcher ME, Begley A, Houck PR, Mazumdar S, Reynolds CF 3rd, Monk TH. Efficacy of brief behavioral treatment for chronic insomnia in older adults. Arch Intern Med. 2011 May 23;171(10):887-95. doi: 10.1001/archinternmed.2010.535. Epub 2011 Jan 24. Erratum in: JAMA Intern Med. 2019 Jun 17;:.
- Morin CM, Colecchi C, Stone J, Sood R, Brink D. Behavioral and pharmacological therapies for late-life insomnia: a randomized controlled trial. JAMA. 1999 Mar 17;281(11):991-9.
- Backhaus J, Hohagen F, Voderholzer U, Riemann D. Long-term effectiveness of a short-term cognitive-behavioral group treatment for primary insomnia. Eur Arch Psychiatry Clin Neurosci. 2001;251(1):35-41.
- Jacobs GD, Pace-Schott EF, Stickgold R, Otto MW. Cognitive behavior therapy and pharmacotherapy for insomnia: a randomized controlled trial and direct comparison. Arch Intern Med. 2004 Sep 27;164(17):1888-96.
- Sivertsen B, Omvik S, Pallesen S, Bjorvatn B, Havik OE, Kvale G, Nielsen GH, Nordhus IH. Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial. JAMA. 2006 Jun 28;295(24):2851-8.
- Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioral therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001 Apr 11;285(14):1856-64.
- Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35.
- Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95.
- Arnedt JT, Conroy DA, Armitage R, Brower KJ. Cognitive-behavioral therapy for insomnia in alcohol dependent patients: a randomized controlled pilot trial. Behav Res Ther. 2011 Apr;49(4):227-33. doi: 10.1016/j.brat.2011.02.003. Epub 2011 Feb 15.
- Substance A, Mental Health Services Administration CfBHS, Quality. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. Rockville, MD: United States Department of Health and Human Services, Substance Abuse and Mental Health Services Administration;2014.
- Stinson FS, Ruan WJ, Pickering R, Grant BF. Cannabis use disorders in the USA: prevalence, correlates and co-morbidity. Psychol Med. 2006 Oct;36(10):1447-60. Epub 2006 Jul 20.
- Adefuye AS, Abiona TC, Balogun JA, Lukobo-Durrell M. HIV sexual risk behaviors and perception of risk among college students: implications for planning interventions. BMC Public Health. 2009 Aug 4;9:281. doi: 10.1186/1471-2458-9-281.
- Naar-King S, Kolmodin K, Parsons JT, Murphy D; ATN 004 Protocol Team, Adolescent Trials Network for HIV/AIDS Interventions. Psychosocial factors and substance use in high-risk youth living with HIV: a multi-site study. AIDS Care. 2010 Apr;22(4):475-82. doi: 10.1080/09540120903220279.
- Brodbeck J, Matter M, Moggi F. Association between cannabis use and sexual risk behavior among young heterosexual adults. AIDS Behav. 2006 Sep;10(5):599-605.
- Bachhuber MA, Saloner B, Cunningham CO, Barry CL. Medical cannabis laws and opioid analgesic overdose mortality in the United States, 1999-2010. JAMA Intern Med. 2014 Oct;174(10):1668-73. doi: 10.1001/jamainternmed.2014.4005. Erratum in: JAMA Intern Med. 2014 Nov;174(11):1875.
- Hadland SE, Knight JR, Harris SK. Medical marijuana: review of the science and implications for developmental-behavioral pediatric practice. J Dev Behav Pediatr. 2015 Feb-Mar;36(2):115-23. doi: 10.1097/DBP.0000000000000129. Review.
- Jensen B, Chen J, Furnish T, Wallace M. Medical Marijuana and Chronic Pain: a Review of Basic Science and Clinical Evidence. Curr Pain Headache Rep. 2015 Oct;19(10):50. doi: 10.1007/s11916-015-0524-x. Review.
- Whiting PF, Wolff RF, Deshpande S, Di Nisio M, Duffy S, Hernandez AV, Keurentjes JC, Lang S, Misso K, Ryder S, Schmidlkofer S, Westwood M, Kleijnen J. Cannabinoids for Medical Use: A Systematic Review and Meta-analysis. JAMA. 2015 Jun 23-30;313(24):2456-73. doi: 10.1001/jama.2015.6358. Review. Erratum in: JAMA. 2015 Aug 4;314(5):520. JAMA. 2015 Aug 25;314(8):837. Erratum in: JAMA. 2015 Dec 1;314(21):2308. JAMA. 2016 Apr 12;315(14):1522.
- Cerdá M, Wall M, Keyes KM, Galea S, Hasin D. Medical marijuana laws in 50 states: investigating the relationship between state legalization of medical marijuana and marijuana use, abuse and dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):22-7. doi: 10.1016/j.drugalcdep.2011.06.011. Epub 2011 Nov 17.
- Mason WA, Fleming CB, Ringle JL, Hanson K, Gross TJ, Haggerty KP. Prevalence of marijuana and other substance use before and after Washington State's change from legal medical marijuana to legal medical and nonmedical marijuana: Cohort comparisons in a sample of adolescents. Subst Abus. 2016 Apr-Jun;37(2):330-5. doi: 10.1080/08897077.2015.1071723. Epub 2015 Aug 7.
- Pacula RL, Powell D, Heaton P, Sevigny EL. Assessing the effects of medical marijuana laws on marijuana use: the devil is in the details. J Policy Anal Manage. 2015 Winter;34(1):7-31.
- Cousens K, DiMascio A. (-) Delta 9 THC as an hypnotic. An experimental study of three dose levels. Psychopharmacologia. 1973 Dec 20;33(4):355-64.
- Feinberg I, Jones R, Walker JM, Cavness C, March J. Effects of high dosage delta-9-tetrahydrocannabinol on sleep patterns in man. Clin Pharmacol Ther. 1975 Apr;17(4):458-66.
- Gillin J, Kotin J, Post R. Sleep during one week of administration of Δ-9 tetrahydrocanabinol to psychiatric patients. J Sleep Res. 1972;1:44.
- Barratt ES, Beaver W, White R. The effects of marijuana on human sleep patterns. Biol Psychiatry. 1974 Feb;8(1):47-54.
- Babson KA, Boden MT, Bonn-Miller MO. The impact of perceived sleep quality and sleep efficiency/duration on cannabis use during a self-guided quit attempt. Addict Behav. 2013 Nov;38(11):2707-13. doi: 10.1016/j.addbeh.2013.06.012. Epub 2013 Jul 2.
- Bolla KI, Lesage SR, Gamaldo CE, Neubauer DN, Wang NY, Funderburk FR, Allen RP, David PM, Cadet JL. Polysomnogram changes in marijuana users who report sleep disturbances during prior abstinence. Sleep Med. 2010 Oct;11(9):882-9. doi: 10.1016/j.sleep.2010.02.013. Epub 2010 Aug 3.
- Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. doi: 10.1016/j.drugalcdep.2011.01.003. Epub 2011 Feb 5.
- Bolla KI, Eldreth DA, Matochik JA, Cadet JL. Neural substrates of faulty decision-making in abstinent marijuana users. Neuroimage. 2005 Jun;26(2):480-92. Epub 2005 Mar 23.
- Bolla KI, Lesage SR, Gamaldo CE, Neubauer DN, Funderburk FR, Cadet JL, David PM, Verdejo-Garcia A, Benbrook AR. Sleep disturbance in heavy marijuana users. Sleep. 2008 Jun;31(6):901-8.
- Roane BM, Taylor DJ. Adolescent insomnia as a risk factor for early adult depression and substance abuse. Sleep. 2008 Oct;31(10):1351-6.
- Taylor DJ, Bramoweth AD. Patterns and consequences of inadequate sleep in college students: substance use and motor vehicle accidents. J Adolesc Health. 2010 Jun;46(6):610-2. doi: 10.1016/j.jadohealth.2009.12.010. Epub 2010 Feb 25.
- Budney AJ, Moore BA, Vandrey RG, Hughes JR. The time course and significance of cannabis withdrawal. J Abnorm Psychol. 2003 Aug;112(3):393-402.
- Babson KA, Blonigen DM, Boden MT, Drescher KD, Bonn-Miller MO. Sleep quality among U.S. military veterans with PTSD: a factor analysis and structural model of symptoms. J Trauma Stress. 2012 Dec;25(6):665-74. doi: 10.1002/jts.21757.
- Budney AJ, Vandrey RG, Hughes JR, Thostenson JD, Bursac Z. Comparison of cannabis and tobacco withdrawal: severity and contribution to relapse. J Subst Abuse Treat. 2008 Dec;35(4):362-8. doi: 10.1016/j.jsat.2008.01.002. Epub 2008 Mar 14.
- Levin KH, Copersino ML, Heishman SJ, Liu F, Kelly DL, Boggs DL, Gorelick DA. Cannabis withdrawal symptoms in non-treatment-seeking adult cannabis smokers. Drug Alcohol Depend. 2010 Sep 1;111(1-2):120-7. doi: 10.1016/j.drugalcdep.2010.04.010. Epub 2010 May 26.
- Babson KA, Boden MT, Harris AH, Stickle TR, Bonn-Miller MO. Poor sleep quality as a risk factor for lapse following a cannabis quit attempt. J Subst Abuse Treat. 2013 Apr;44(4):438-43. doi: 10.1016/j.jsat.2012.08.224. Epub 2012 Oct 23.
- Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am. 1987 Dec;10(4):541-53. Review.
- Schafer J, Brown SA. Marijuana and cocaine effect expectancies and drug use patterns. J Consult Clin Psychol. 1991 Aug;59(4):558-65.
- Friedmann PD, Herman DS, Freedman S, Lemon SC, Ramsey S, Stein MD. Treatment of sleep disturbance in alcohol recovery: a national survey of addiction medicine physicians. J Addict Dis. 2003;22(2):91-103.
- Griffiths RR, Johnson MW. Relative abuse liability of hypnotic drugs: a conceptual framework and algorithm for differentiating among compounds. J Clin Psychiatry. 2005;66 Suppl 9:31-41.
- Brower KJ, McCammon RJ, Wojnar M, Ilgen MA, Wojnar J, Valenstein M. Prescription sleeping pills, insomnia, and suicidality in the National Comorbidity Survey Replication. J Clin Psychiatry. 2011 Apr;72(4):515-21. doi: 10.4088/JCP.09m05484gry. Epub 2010 Sep 21.
- Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006 Nov;29(11):1398-414. Review.
- Edinger JD, Olsen MK, Stechuchak KM, Means MK, Lineberger MD, Kirby A, Carney CE. Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial. Sleep. 2009 Apr;32(4):499-510.
- Vitiello MV, Rybarczyk B, Von Korff M, Stepanski EJ. Cognitive behavioral therapy for insomnia improves sleep and decreases pain in older adults with co-morbid insomnia and osteoarthritis. J Clin Sleep Med. 2009 Aug 15;5(4):355-62.
- Morin CM, Bastien C, Guay B, Radouco-Thomas M, Leblanc J, Vallières A. Randomized clinical trial of supervised tapering and cognitive behavior therapy to facilitate benzodiazepine discontinuation in older adults with chronic insomnia. Am J Psychiatry. 2004 Feb;161(2):332-42.
- Miller CB, Kyle SD, Marshall NS, Espie CA. Ecological momentary assessment of daytime symptoms during sleep restriction therapy for insomnia. J Sleep Res. 2013 Jun;22(3):266-72. doi: 10.1111/jsr.12024. Epub 2013 Jan 19.
- Kyle SD, Morgan K, Spiegelhalder K, Espie CA. No pain, no gain: an exploratory within-subjects mixed-methods evaluation of the patient experience of sleep restriction therapy (SRT) for insomnia. Sleep Med. 2011 Sep;12(8):735-47. doi: 10.1016/j.sleep.2011.03.016. Epub 2011 Sep 9.
- Babson KA, Ramo DE, Baldini L, Vandrey R, Bonn-Miller MO. Mobile App-Delivered Cognitive Behavioral Therapy for Insomnia: Feasibility and Initial Efficacy Among Veterans With Cannabis Use Disorders. JMIR Res Protoc. 2015 Jul 17;4(3):e87. doi: 10.2196/resprot.3852.
- Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.
- Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249.
- Ilgen MA, Bohnert K, Kleinberg F, Jannausch M, Bohnert AS, Walton M, Blow FC. Characteristics of adults seeking medical marijuana certification. Drug Alcohol Depend. 2013 Oct 1;132(3):654-9. doi: 10.1016/j.drugalcdep.2013.04.019. Epub 2013 May 15.
- Bohnert KM, Perron BE, Ashrafioun L, Kleinberg F, Jannausch M, Ilgen MA. Positive posttraumatic stress disorder screens among first-time medical cannabis patients: prevalence and association with other substance use. Addict Behav. 2014 Oct;39(10):1414-7. doi: 10.1016/j.addbeh.2014.05.022. Epub 2014 Jun 2.
- Ashrafioun L, Bohnert KM, Jannausch M, Ilgen MA. Characteristics of substance use disorder treatment patients using medical cannabis for pain. Addict Behav. 2015 Mar;42:185-8. doi: 10.1016/j.addbeh.2014.11.024. Epub 2014 Nov 26.
- Perron BE, Bohnert K, Perone AK, Bonn-Miller MO, Ilgen M. Use of prescription pain medications among medical cannabis patients: comparisons of pain levels, functioning, and patterns of alcohol and other drug use. J Stud Alcohol Drugs. 2015 May;76(3):406-13.
- Cranford JA, Arnedt JT, Conroy DA, Bohnert KM, Bourque C, Blow FC, Ilgen M. Prevalence and correlates of sleep-related problems in adults receiving medical cannabis for chronic pain. Drug Alcohol Depend. 2017 Nov 1;180:227-233. doi: 10.1016/j.drugalcdep.2017.08.017. Epub 2017 Sep 9.
- Steinmark SW, Borkovec TD. Active and placebo treatment effects on moderate insomnia under counterdemand and positive demand instructions. J Abnorm Psychol. 1974 Apr;83(2):157-63.
- Arnedt JT, Cuddihy L, Swanson LM, Pickett S, Aikens J, Chervin RD. Randomized controlled trial of telephone-delivered cognitive behavioral therapy for chronic insomnia. Sleep. 2013 Mar 1;36(3):353-62. doi: 10.5665/sleep.2448.
- Arnedt JT, Swanson LM, Dopp RR, Bertram HS, Mooney AJ, Huntley ED, Hoffmann RF, Armitage R. Effects of Restricted Time in Bed on Antidepressant Treatment Response: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Oct;77(10):e1218-e1225. doi: 10.4088/JCP.15m09879.
- Association AP. Diagnostic and Statistical Manual of Mental Disorders (DSM-5®): American Psychiatric Pub; 2013.
- Carney CE, Buysse DJ, Ancoli-Israel S, Edinger JD, Krystal AD, Lichstein KL, Morin CM. The consensus sleep diary: standardizing prospective sleep self-monitoring. Sleep. 2012 Feb 1;35(2):287-302. doi: 10.5665/sleep.1642.
- Morin CM. Insomnia: Psychological assessment and management. New York: The Guilford Press; 1993.
- Spielman AJ, Saskin P, Thorpy MJ. Treatment of chronic insomnia by restriction of time in bed. Sleep. 1987 Feb;10(1):45-56.
- Bootzin RR, Nicassio PM. Behavioral treatments for insomnia. In: Hersen M, Eissler R, Miller P, eds. Progress in Behavior Modification. Vol 6. New York, NY: Academic Press; 1978:1-45.
- Fellman-Couture C, Pillai V, Arnedt JT, et al. Long-term Efficacy of Cognitive Behavior Therapy for Menopausal Insomnia. Sleep. Denver, CO2016.
- Manber R, Carney C, Edinger J, Epstein D, Friedman L, Haynes PL, Karlin BE, Pigeon W, Siebern AT, Trockel M. Dissemination of CBTI to the non-sleep specialist: protocol development and training issues. J Clin Sleep Med. 2012 Apr 15;8(2):209-18. doi: 10.5664/jcsm.1786.
- Quesnel C, Savard J, Simard S, Ivers H, Morin CM. Efficacy of cognitive-behavioral therapy for insomnia in women treated for nonmetastatic breast cancer. J Consult Clin Psychol. 2003 Feb;71(1):189-200.
- Perlis M, Jungquist C, Smith M, Posner D. Cognitive behavioral therapy for insomnia: a session-by-session guide: Springer, New York; 2005.
- Carroll KM, Nich C, Sifry RL, Nuro KF, Frankforter TL, Ball SA, Fenton L, Rounsaville BJ. A general system for evaluating therapist adherence and competence in psychotherapy research in the addictions. Drug Alcohol Depend. 2000 Jan 1;57(3):225-38.
- Iber C, Ancoli-Israel S, Chesson A, Quan SFftAAoSM. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specifications, 1st ed. Westchester, Illinois: American Academy of Sleep Medicine; 2007.
- Berry RB, R. Brooks, C. E. Gamaldo, et al. The AASM manual for the scoring of sleep and associated events: rules, terminology and technical specifications, Version 2.1. Darien, IL, : American Academy of Sleep Medicine; 2014.
- Jasper HH. The ten twenty electrode system of the international federation. Electroencephalography and clinical neurophysiology. 1958;10:371-375.
- Putnam LE, Johnson R Jr, Roth WT. Guidelines for reducing the risk of disease transmission in the psychophysiology laboratory. SPR Ad Hoc Committee on the Prevention of Disease Transmission. Psychophysiology. 1992 Mar;29(2):127-41.
- Armitage R, Rush AJ, Trivedi M, Cain J, Roffwarg HP. The effects of nefazodone on sleep architecture in depression. Neuropsychopharmacology. 1994 Apr;10(2):123-7.
- Ancoli-Israel S, Martin JL, Blackwell T, Buenaver L, Liu L, Meltzer LJ, Sadeh A, Spira AP, Taylor DJ. The SBSM Guide to Actigraphy Monitoring: Clinical and Research Applications. Behav Sleep Med. 2015;13 Suppl 1:S4-S38. doi: 10.1080/15402002.2015.1046356.
- Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13.
- Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res. 1995 Apr;39(3):315-25.
- Smith GE, Ross RL, Rost KM. Psychiatric outcomes module: substance abuse outcomes module (SAOM). In: Sederer LI, Dickey B, eds. Outcome assessment in clinical practice. Baltimore, MD: Williams and Wilkins; 1996:85-88.
- Copeland J, Gilmour S, Gates P, Swift W. The Cannabis Problems Questionnaire: factor structure, reliability, and validity. Drug Alcohol Depend. 2005 Dec 12;80(3):313-9.
- Lacks P. Behavioral Treatment for Persistent Insomnia. New York, NY: Pergamon Press; 1987.
- Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep. 2007 Feb;30(2):203-12.
- Fichten CS, Libman E, Creti L, et al. Role of thoughts during nocturnal awake times in the insomnia experience of older adults. Cognitive Therapy and Research. 2001;25(6):665-692.
- Slavet JD, Stein LA, Colby SM, Barnett NP, Monti PM, Golembeske C Jr, Lebeau-Craven R. The Marijuana Ladder: measuring motivation to change marijuana use in incarcerated adolescents. Drug Alcohol Depend. 2006 Jun 9;83(1):42-8. Epub 2005 Nov 14.
- Simons J, Correia CJ, Carey KB, Borsari BE. Validating a five-factor marijuana motives measure: Relations with use, problems, and alcohol motives. Journal of Counseling Psychology. 1998;45(3):265.
- Zvolensky MJ, Vujanovic AA, Bernstein A, Bonn-Miller MO, Marshall EC, Leyro TM. Marijuana use motives: A confirmatory test and evaluation among young adult marijuana users. Addict Behav. 2007 Dec;32(12):3122-30. Epub 2007 Jun 9.
- Torrealday O, Stein LA, Barnett N, Golembeske C, Lebeau R, Colby SM, Monti PM. Validation of the Marijuana Effect Expectancy Questionnaire-Brief. J Child Adolesc Subst Abuse. 2008;17(4):1-17.
- Sobell MB, Sobell LC, Klajner F, Pavan D, Basian E. The reliability of a timeline method for assessing normal drinker college students' recent drinking history: utility for alcohol research. Addict Behav. 1986;11(2):149-61.
- Sobell LC, Sobell MB. Timeline follow-back. Measuring alcohol consumption: Springer; 1992:41-72.
- Hjorthøj CR, Hjorthøj AR, Nordentoft M. Validity of Timeline Follow-Back for self-reported use of cannabis and other illicit substances--systematic review and meta-analysis. Addict Behav. 2012 Mar;37(3):225-33. doi: 10.1016/j.addbeh.2011.11.025. Epub 2011 Nov 26. Review.
- Conroy DA, Todd Arnedt J, Brower KJ, Strobbe S, Consens F, Hoffmann R, Armitage R. Perception of sleep in recovering alcohol-dependent patients with insomnia: relationship with future drinking. Alcohol Clin Exp Res. 2006 Dec;30(12):1992-9. Erratum in: Alcohol Clin Exp Res. 2007 May;31(5):907.
- Little RJ, Rubin DB. Statistical analysis with missing data. New York: Wiley & Sons; 1987.
- Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
- Hall DB. Zero-inflated Poisson and binomial regression with random effects: a case study. Biometrics. 2000 Dec;56(4):1030-9.
- Kraemer HC, Stice E, Kazdin A, Offord D, Kupfer D. How do risk factors work together? Mediators, moderators, and independent, overlapping, and proxy risk factors. Am J Psychiatry. 2001 Jun;158(6):848-56. Review.
- Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877-83. Review.
- Preacher KJ, Hayes AF. SPSS and SAS procedures for estimating indirect effects in simple mediation models. Behav Res Methods Instrum Comput. 2004 Nov;36(4):717-31.
- Banes KE, Stephens RS, Blevins CE, Walker DD, Roffman RA. Changing motives for use: outcomes from a cognitive-behavioral intervention for marijuana-dependent adults. Drug Alcohol Depend. 2014 Jun 1;139:41-6. doi: 10.1016/j.drugalcdep.2014.02.706. Epub 2014 Mar 15.
- Blevins CE, Banes KE, Stephens RS, Walker DD, Roffman RA. Motives for marijuana use among heavy-using high school students: An analysis of structure and utility of the Comprehensive Marijuana Motives Questionnaire. Addict Behav. 2016 Jun;57:42-7. doi: 10.1016/j.addbeh.2016.02.005. Epub 2016 Feb 8.
- Blevins CE, Banes KE, Stephens RS, Walker DD, Roffman RA. Change in motives among frequent cannabis-using adolescents: Predicting treatment outcomes. Drug Alcohol Depend. 2016 Oct 1;167:175-81. doi: 10.1016/j.drugalcdep.2016.08.018. Epub 2016 Aug 21.
- Hori T, Sugita Y, Koga E, Shirakawa S, Inoue K, Uchida S, Kuwahara H, Kousaka M, Kobayashi T, Tsuji Y, Terashima M, Fukuda K, Fukuda N; Sleep Computing Committee of the Japanese Society of Sleep Research Society. Proposed supplements and amendments to 'A Manual of Standardized Terminology, Techniques and Scoring System for Sleep Stages of Human Subjects', the Rechtschaffen & Kales (1968) standard. Psychiatry Clin Neurosci. 2001 Jun;55(3):305-10.
- Marijuana Treatment Project Research Group. Brief treatments for cannabis dependence: findings from a randomized multisite trial. J Consult Clin Psychol. 2004 Jun;72(3):455-66.
|Same as current
|December 2021 (Final data collection date for primary outcome measure)
- Age 21 years or older
- Insomnia Severity Index (ISI) score greater than 10 (indicating mild insomnia),
- Use of cannabis on average three times a week for the past three months,
- Self-reported use of cannabis to manage insomnia at least once a week over the past month,
- Positive drug screen for THC,
- Consistent access to a telephone, smartphone, laptop, or tablet
- Individuals who do not understand English,
- Individuals judged unable to provide informed consent (e.g. intoxication, mental incompetence),
- Diagnosis or high suspicion of a sleep disorder based on validated self-report questionnaires,
- Self-reported cancer,
- Self-reported pregnancy,
- Self-reported rotating or night (3rd) shift work.
- Participants taking medications for sleep will be included if they meet study criteria for insomnia, medications have been stable for at least 8 weeks, and they agree to maintain the same regimen throughout the study.
|Sexes Eligible for Study:
|21 Years and older (Adult, Older Adult)
1R34DA047466-01 ( U.S. NIH Grant/Contract )
|Studies a U.S. FDA-regulated Drug Product:
|Studies a U.S. FDA-regulated Device Product:
|Mark A. Ilgen, University of Michigan
|University of Michigan
|National Institute on Drug Abuse (NIDA)
|University of Michigan