InsomniaNCT05973955
Adapting CBT-I for Hazardous Alcohol Users
A study testing Insomnia Treatment in people with Insomnia and Harmful; Use, Alcohol, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this intervention development trial is to develop, refine, and test a telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted to hazardous alcohol users with co-occurring insomnia. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Insomnia, Harmful; Use, Alcohol
- What is being tested?
- Insomnia Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- comprehension of written and spoken English (because we are developing and testing a new intervention for which translated materials are not available);
- living in New York State (self-report);
- Alcohol Use Disorder Identification Test (AUDIT) score of 8-15 to identify alcohol use that is in the hazardous zone;
- current alcohol use (past 30 days) in excess of low-risk drinking guidelines as defined by U.S. Department of Health and Human Services and U.S. Department of Agriculture's 2015-2020 Dietary Guidelines for Americans using four items: items are 1) any use of alcohol; 2) the number of days that alcohol was used; 3) on days of alcohol use, the usual number of drinks; 4) number of days with 4/5 or more drinks on the same "occasion" defined as "at the same time or within a couple hours of each other". Based on these responses, we will determine if the individual exceeds low-risk drinking guidelines;
- Insomnia Severity Index (ISI) score > 8; and
- meet Diagnostic and Statistical Manual of Mental Disorders (5th edition; [DSM 5]) criteria for Insomnia Disorder (this is evaluated by answers on the ISI supplemented by interview questions).
Who cannot join
- having received Cognitive Behavioral Therapy for Insomnia (by self-report and follow-up question prompts as needed);
- current or recent (past year) professional alcohol treatment (from self-report and prompts), however, participants who only report beginning alcohol treatment during the follow-up period will not be excluded from completing any remaining follow-up assessments, but this will be recorded in the data and assessed as a potential covariate.
- current or recent (past year) intravenous drug use or non-prescribed use of stimulant medications (e.g., cocaine, methamphetamines) (from TLFB and self-report question prompts);
- hospice patients, patients undergoing oncology treatment, patients with a recent or upcoming surgery and/or endorsing a serious medical or psychiatric condition item from a conditions and medications form administered by the Assessor);
- endorsing current suicidal ideation (past two weeks) with either a prior suicide attempt or being assessed at higher risk for suicide by the "P4 Screener" (a suicide risk screen used in both clinical settings and clinical trials);
- current pregnancy or intent to become pregnant during the next 6 months or given birth in the past 3 months or currently breast-feeding;
- significant sleep disorders other than insomnia such as narcolepsy or untreated sleep apnea with a Body Mass Index > 32 (from self-report and the validated Sleep Disorders Questionnaire screening instrument) although those receiving care for sleep apnea, however, (e.g., positive airway pressure therapy) will be eligible; and
- providing false information such as false name, contact information, or study responses.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Addressing Hazardous and Harmful Alcohol Use Through an Adapted CBT Sleep Intervention
The goal of this intervention development trial is to develop, refine, and test a telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted to hazardous alcohol users with co-occurring insomnia. The project will begin with a small, open label pilot to refine the intervention and proceed to a small, randomized trial comparing the intervention to a sleep and alcohol education control condition.
The two main questions it aims to answer are whether the intervention is feasible to deliver and whether its effects on alcohol use and insomnia severity are large enough to warrant further work.
Read the detailed description
Drinking problems and sleep problems each cause significant loss at individual and societal levels. Insomnia in particular is highly prevalent in patients with alcohol use disorder, is prospectively associated with the development of alcohol use disorder and contributes to poorer recovery prognosis following alcohol treatments. Insomnia, therefore, represents a modifiable risk factor for negative outcomes associated with alcohol use along the full continuum of alcohol use problems.
Accordingly, the project proposes to improve sleep with an insomnia intervention (cognitive behavioral therapy for insomnia) tailored to adults who meet widely accepted definitions for hazardous alcohol use as well as diagnostic criteria for insomnia disorder. An iterative approach to development, refinement, and preliminary examination of the utility of a telephone-delivered, 4-session intervention will be used. A small (N = 10), open label pilot to develop and refine procedures for administering the intervention is followed by a small (N=60), randomized trial comparing the intervention to a sleep and alcohol education control condition. A number of intervention and study design feasibility domains will be assessed in preparation for designing a larger study. The investigators will also assess the effects of the intervention on alcohol use, sleep and mood by measuring these outcomes at baseline, post-treatment, and at 3- and 6-month follow up assessments.
- Conditions
- Insomnia, Harmful; Use, Alcohol
- Being tested
- Insomnia Treatment, Education Control
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insomnia TreatmentBehavioural
Also called CBTi-HAU
The Insomnia Treatment is a version of Cognitive Behavioral Therapy for Insomnia adapted to individuals with hazardous alcohol use. It consists of the standard features of this well-established insomnia treatment in addition to adaptations that focus on alcohol use behaviors and alcohol-related thoughts that may be sleep-interfering as well as the provision of alcohol education material.
Education ControlBehavioural
Also called Alcohol & Sleep Education
The Education Control intervention is an educational control that provides psychoeducation related to both sleep and to alcohol use.
| Study group | Role | What they receive |
|---|---|---|
| Education Control | Placebo comparator | A combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks. Receives: Behavioral: Education Control |
| Insomnia Treatment | Experimental | Cognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks. Receives: Behavioral: Insomnia Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence
The percentage of days abstinent (PDA) as measured by the Timeline Followback (TLFB)
Measured: 6 months following the baseline assessment
Drinks per Drinking Day
The average number of drinks per drinking day (DDD) as measured by the Timeline Followback (TLFB)
Measured: 6 months following the baseline assessment
Insomnia Severity
The average total score on the Insomnia Severity Index (ISI)
Measured: 6 months following the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start22 Mar 2024
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilfred Pigeon, PhD, University of Rochester
- Investigators
- Wilfred R Pigeon, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973955
- Sponsor's protocol ID
- STUDY00008187
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be submitted to a data archive: the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive. The study will submit data to the National Data Archive (NDA) according to all requirements and expectations per NOT-AA-22-003.
Publications
Pigeon WR, Bishop TM, Arnedt JT, Duberstein Z, Mihaila AG, Jones J, Conner KR. Cognitive behavioral therapy for insomnia modified for adults with hazardous alcohol use: an open-label pilot study. Sleep Adv. 2026 Jan 8;7(1):zpag002. doi: 10.1093/sleepadvances/zpag002. eCollection 2026.
PubMed 41768371
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Hazardous and Harmful Alcohol Use Through an Adapted CBT Sleep Intervention
- ClinicalTrials.gov ID
- NCT05973955
- Acronym / sponsor ID
- STUDY00008187
- Conditions
- Insomnia, Harmful; Use, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this intervention development trial is to develop, refine, and test a telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted to hazardous alcohol users with co-occurring insomnia. The project will begin with a small, open label pilot to refine the intervention and proceed to a small, randomized trial comparing the intervention to a sleep and alcohol education control condition.
The two main questions it aims to answer are whether the intervention is feasible to deliver and whether its effects on alcohol use and insomnia severity are large enough to warrant further work.
Detailed description
Drinking problems and sleep problems each cause significant loss at individual and societal levels. Insomnia in particular is highly prevalent in patients with alcohol use disorder, is prospectively associated with the development of alcohol use disorder and contributes to poorer recovery prognosis following alcohol treatments. Insomnia, therefore, represents a modifiable risk factor for negative outcomes associated with alcohol use along the full continuum of alcohol use problems.
Accordingly, the project proposes to improve sleep with an insomnia intervention (cognitive behavioral therapy for insomnia) tailored to adults who meet widely accepted definitions for hazardous alcohol use as well as diagnostic criteria for insomnia disorder. An iterative approach to development, refinement, and preliminary examination of the utility of a telephone-delivered, 4-session intervention will be used. A small (N = 10), open label pilot to develop and refine procedures for administering the intervention is followed by a small (N=60), randomized trial comparing the intervention to a sleep and alcohol education control condition. A number of intervention and study design feasibility domains will be assessed in preparation for designing a larger study. The investigators will also assess the effects of the intervention on alcohol use, sleep and mood by measuring these outcomes at baseline, post-treatment, and at 3- and 6-month follow up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Control | Placebo comparator | Behavioral: Education ControlA combination of alcohol education and sleep hygiene education comprised of four telephone-based sessions delivered over six weeks. |
| Insomnia Treatment | Experimental | Behavioral: Insomnia TreatmentCognitive-behavioral therapy for insomnia adapted to hazardous alcohol users comprised of four telephone-based sessions delivered over six weeks. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- comprehension of written and spoken English (because we are developing and testing a new intervention for which translated materials are not available);
- living in New York State (self-report);
- Alcohol Use Disorder Identification Test (AUDIT) score of 8-15 to identify alcohol use that is in the hazardous zone;
- current alcohol use (past 30 days) in excess of low-risk drinking guidelines as defined by U.S. Department of Health and Human Services and U.S. Department of Agriculture's 2015-2020 Dietary Guidelines for Americans using four items: items are 1) any use of alcohol; 2) the number of days that alcohol was used; 3) on days of alcohol use, the usual number of drinks; 4) number of days with 4/5 or more drinks on the same "occasion" defined as "at the same time or within a couple hours of each other". Based on these responses, we will determine if the individual exceeds low-risk drinking guidelines;
- Insomnia Severity Index (ISI) score > 8; and
Key exclusion criteria (8 listed)
- having received Cognitive Behavioral Therapy for Insomnia (by self-report and follow-up question prompts as needed);
- current or recent (past year) professional alcohol treatment (from self-report and prompts), however, participants who only report beginning alcohol treatment during the follow-up period will not be excluded from completing any remaining follow-up assessments, but this will be recorded in the data and assessed as a potential covariate.
- current or recent (past year) intravenous drug use or non-prescribed use of stimulant medications (e.g., cocaine, methamphetamines) (from TLFB and self-report question prompts);
- hospice patients, patients undergoing oncology treatment, patients with a recent or upcoming surgery and/or endorsing a serious medical or psychiatric condition item from a conditions and medications form administered by the Assessor);
- endorsing current suicidal ideation (past two weeks) with either a prior suicide attempt or being assessed at higher risk for suicide by the "P4 Screener" (a suicide risk screen used in both clinical settings and clinical trials);
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 |
|---|---|---|
| Insomnia TreatmentAlso: CBTi-HAUThe Insomnia Treatment is a version of Cognitive Behavioral Therapy for Insomnia adapted to individuals with hazardous alcohol use. It consists of the standard features of this well-established insomnia treatment in addition to adaptations that focus on alcohol use behaviors and alcohol-related thoughts that may be sleep-interfering as well as the provision of alcohol education material. | Behavioural | Insomnia Treatment |
| Education ControlAlso: Alcohol & Sleep EducationThe Education Control intervention is an educational control that provides psychoeducation related to both sleep and to alcohol use. | Behavioural | Education Control |
Primary outcome
Abstinence
Time frame: 6 months following the baseline assessment
The percentage of days abstinent (PDA) as measured by the Timeline Followback (TLFB)
Drinks per Drinking Day
Time frame: 6 months following the baseline assessment
The average number of drinks per drinking day (DDD) as measured by the Timeline Followback (TLFB)
Insomnia Severity
Time frame: 6 months following the baseline assessment
The average total score on the Insomnia Severity Index (ISI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 41768371Pigeon WR, Bishop TM, Arnedt JT, Duberstein Z, Mihaila AG, Jones J, Conner KR. Cognitive behavioral therapy for insomnia modified for adults with hazardous alcohol use: an open-label pilot study. Sleep Adv. 2026 Jan 8;7(1):zpag002. doi: 10.1093/sleepadvances/zpag002. eCollection 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be submitted to a data archive: the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Data Archive. The study will submit data to the National Data Archive (NDA) according to all requirements and expectations per NOT-AA-22-003.
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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.
Wilfred R Pigeon, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insomnia Treatment in people with Insomnia and Harmful; Use, Alcohol, run by University of Rochester 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 4 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Abstinence (time frame: 6 months following the baseline assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05973955, which also lists 1 linked publication.
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 4 Sep 2026; AzTrials last refreshed its copy on 29 Oct 2026.