Marijuana AbuseCBT-I-CUNCT02102230
CBT-I for Cannabis Use
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) and Desensitization Treatment for Insomnia in people with Marijuana Abuse and Sleep Initiation and Maintenance Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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 sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marijuana Abuse, Sleep Initiation and Maintenance Disorders
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) and Desensitization Treatment for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2014to 24 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in the current study individuals must
- be a Veteran 18 years or older
- meet Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for cannabis use disorder;
- meet Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for insomnia;
Who cannot join
- Individuals will be excluded based on evidence of the following:
- inability to provide fully-informed written consent to participate;
- history of, or current, psychotic symptoms;
- current pregnancy;
- Sleep apnea (>5 on the STOP-Bang assessment);
- active suicidal/homicidal intent.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Official title: The Impact of CBT-I on Cannabis Cessation Outcomes
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 sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans.
Read the detailed description
The Prevalence of cannabis use disorder (CUD) has been steadily increasing within the Veteran Health Administration (VHA), along with the related significant physical, cognitive, and psychological sequelae. Even in patients with a strong motivation to quit and the presence of empirically-supported interventions, Veterans who receive treatment for CUD have high rates of lapse (63% by 6-months post-treatment) and relapse (71% within 6-months post-treatment). Thus, identifying strategies to improve response to CUD treatment is in the interest of all VHA stakeholders.
Disturbed sleep is common among individuals with CUD and has been shown to result in increased rates of lapse/relapse to cannabis. Providing a behavioral sleep intervention within the context of CUD treatment, and prior to a cessation attempt, has the potential to improve these cessation outcomes.
Cognitive behavioral therapy for insomnia (CBT-I) is a well-established first-line treatment for insomnia. While CBT-I is being disseminated throughout VHA, it is rarely received by Veterans with substance use disorders (SUDs) and, among those that do receive it, it is almost always delivered following a cessation attempt. While CBT-I has been shown to be an effective treatment for improving sleep among individuals with insomnia and co-occurring conditions, including SUDs, there has yet to be an investigation of the impact of providing CBT-I prior to CUD treatment with the goal of improving cessation outcomes. In addition, the development of an adjunct behavioral intervention delivered via mobile app technology within VA holds great promise to bolster outcomes.
The current study seeks to fill this gap by conducting a randomized prospective study designed to evaluate the efficacy of CBT-I, as well as the incremental benefit of including an adjunct sleep mobile app (CBT-I-MA), on both cannabis and sleep outcomes among Veterans with CUD.
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA), Desensitization Treatment for Insomnia
- Keywords
- Sleep Initiation and Maintenance Disorders, marijuana abuse, Veterans
- Medical subject headings
- Marijuana Abuse, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
Also called CBT-I
This is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains.
Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)Behavioural
Also called CBT-I-MA
This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it, along with links to web-based psychoeducational materials, easily accessible to users. The app also provides plots of bed times, wake times, and sleep efficiency over time, with the goal of promoting adherence.
Desensitization Treatment for InsomniaBehavioural
Also called DTI
This is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to "desensitize" the patient to the various aspects of the sleep experience which are presented as distressing.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Experimental | Group Cognitive-Behavioral Therapy for Insomnia (CBT-I) Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| CBT-I-MA | Active comparator | Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) |
| PC | Placebo comparator | Desensitization Treatment for Insomnia (DTI) Receives: Behavioral: Desensitization Treatment for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cannabis Use Frequency Over Time
Measures will include the Timeline Followback for cannabis. All of these measures are standard 7-day point prevalence estimates. In other words, the baseline measure is the number of uses in the 7 days prior to the baseline assessment day. The 6-weeks post-baseline is the number of uses in the 7 days prior to the 6-weeks post-baseline day, and so on.
Measured: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis count of number abstinent
Measured: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Change in Self-reported Sleep Quality Over Time
Self-reported sleep quality will be measured using the Consensus Sleep Diary
Measured: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Change in Objective Sleep Quality Over Time
Objective sleep quality will be measured via actigraphy
Measured: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study start3 Nov 2014
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Why it stopped: Principle Investigator as left government service
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marijuana AbuseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kimberly A Babson, PhD MA BS, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102230
- Sponsor's protocol ID
- CLIN-016-13F
- Acronym
- CBT-I-CU
- Status last verified
- Jul 2019
- First submitted
- 25 Mar 2014
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of CBT-I on Cannabis Cessation Outcomes
- ClinicalTrials.gov ID
- NCT02102230
- Acronym / sponsor ID
- CBT-I-CU / CLIN-016-13F
- Keywords
- Sleep Initiation and Maintenance Disorders, marijuana abuse, Veterans
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principle Investigator as left government service
- Enrolment
- 111 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Nov 2014 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans.
Detailed description
The Prevalence of cannabis use disorder (CUD) has been steadily increasing within the Veteran Health Administration (VHA), along with the related significant physical, cognitive, and psychological sequelae. Even in patients with a strong motivation to quit and the presence of empirically-supported interventions, Veterans who receive treatment for CUD have high rates of lapse (63% by 6-months post-treatment) and relapse (71% within 6-months post-treatment). Thus, identifying strategies to improve response to CUD treatment is in the interest of all VHA stakeholders.
Disturbed sleep is common among individuals with CUD and has been shown to result in increased rates of lapse/relapse to cannabis. Providing a behavioral sleep intervention within the context of CUD treatment, and prior to a cessation attempt, has the potential to improve these cessation outcomes.
Cognitive behavioral therapy for insomnia (CBT-I) is a well-established first-line treatment for insomnia. While CBT-I is being disseminated throughout VHA, it is rarely received by Veterans with substance use disorders (SUDs) and, among those that do receive it, it is almost always delivered following a cessation attempt. While CBT-I has been shown to be an effective treatment for improving sleep among individuals with insomnia and co-occurring conditions, including SUDs, there has yet to be an investigation of the impact of providing CBT-I prior to CUD treatment with the goal of improving cessation outcomes. In addition, the development of an adjunct behavioral intervention delivered via mobile app technology within VA holds great promise to bolster outcomes.
The current study seeks to fill this gap by conducting a randomized prospective study designed to evaluate the efficacy of CBT-I, as well as the incremental benefit of including an adjunct sleep mobile app (CBT-I-MA), on both cannabis and sleep outcomes among Veterans with CUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)Group Cognitive-Behavioral Therapy for Insomnia (CBT-I) |
| CBT-I-MA | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)Group Cognitive-Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) |
| PC | Placebo comparator | Behavioral: Desensitization Treatment for InsomniaDesensitization Treatment for Insomnia (DTI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be included in the current study individuals must
- be a Veteran 18 years or older
- meet Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for cannabis use disorder;
- meet Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for insomnia;
Key exclusion criteria (6 listed)
- inability to provide fully-informed written consent to participate;
- history of, or current, psychotic symptoms;
- current pregnancy;
- Sleep apnea (>5 on the STOP-Bang assessment);
- active suicidal/homicidal intent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I)Also: CBT-IThis is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. | Behavioural | CBT-I |
| Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)Also: CBT-I-MAThis is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it, along with links to web-based psychoeducational materials, easily accessible to users. The app also provides plots of bed times, wake times, and sleep efficiency over time, with the goal of promoting adherence. | Behavioural | CBT-I-MA |
| Desensitization Treatment for InsomniaAlso: DTIThis is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to "desensitize" the patient to the various aspects of the sleep experience which are presented as distressing. | Behavioural | PC |
Primary outcome
Change in Cannabis Use Frequency Over Time
Time frame: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
Measures will include the Timeline Followback for cannabis. All of these measures are standard 7-day point prevalence estimates. In other words, the baseline measure is the number of uses in the 7 days prior to the baseline assessment day. The 6-weeks post-baseline is the number of uses in the 7 days prior to the 6-weeks post-baseline day, and so on.
Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments
Time frame: 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit
point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis count of number abstinent
Change in Self-reported Sleep Quality Over Time
Time frame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Self-reported sleep quality will be measured using the Consensus Sleep Diary
Change in Objective Sleep Quality Over Time
Time frame: 2-weeks post-quit, 4-weeks post-quit, 6-months post-quit
Objective sleep quality will be measured via actigraphy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly A Babson, PhD MA BS principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I), Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA) and Desensitization Treatment for Insomnia in people with Marijuana Abuse and Sleep Initiation and Maintenance Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cannabis Use Frequency Over Time (time frame: baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.