Discontinuation of Hypnotics in Older Veterans
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Insomnia Sleep Studies |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 12/14/2018 |
| Start Date: | December 10, 2018 |
| End Date: | August 31, 2022 |
The Efficacy of Masked Tapering on Discontinuation of Hypnotics in Older Veterans
Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter
of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more
often and have worse memory than those who do not use them. Stopping hypnotics often reverses
these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use
among older adults. Currently, there are two main treatments to help patients stop using
hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic
is ultimately discontinued. For safety, the process of decreasing the daily dose is usually
supervised by a physician. The second is a treatment for insomnia called cognitive behavioral
therapy for insomnia (CBTI).
This study will compare a novel hypnotic tapering method to the usual tapering method offered
to older Veterans. The purpose of the study is to determine if the novel tapering method is
more effective than the usual tapering method, both in terms of hypnotic discontinuation and
improvement in insomnia severity.
Participants will be recruited from among Veterans 60 years and older who receive care from
one VA Healthcare System. Following a baseline assessment, participants will be randomly
assigned to one of the two 8-week treatment groups (66 participants per group). Each
treatment group will receive CBTI, however, one group will receive the novel tapering program
and the other group the usual tapering program. Follow-up assessments will be conducted at
post-treatment and at 6-months after completion of the treatment.
If the novel tapering program is effective, it will represent a treatment option that can be
offered to older Veterans who want to discontinue hypnotics. This tapering program could help
VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine
discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce
the risk of falls and hip fractures, which ultimately may improve the health and quality of
life of older Veterans who receive healthcare at the VA.
of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more
often and have worse memory than those who do not use them. Stopping hypnotics often reverses
these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use
among older adults. Currently, there are two main treatments to help patients stop using
hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic
is ultimately discontinued. For safety, the process of decreasing the daily dose is usually
supervised by a physician. The second is a treatment for insomnia called cognitive behavioral
therapy for insomnia (CBTI).
This study will compare a novel hypnotic tapering method to the usual tapering method offered
to older Veterans. The purpose of the study is to determine if the novel tapering method is
more effective than the usual tapering method, both in terms of hypnotic discontinuation and
improvement in insomnia severity.
Participants will be recruited from among Veterans 60 years and older who receive care from
one VA Healthcare System. Following a baseline assessment, participants will be randomly
assigned to one of the two 8-week treatment groups (66 participants per group). Each
treatment group will receive CBTI, however, one group will receive the novel tapering program
and the other group the usual tapering program. Follow-up assessments will be conducted at
post-treatment and at 6-months after completion of the treatment.
If the novel tapering program is effective, it will represent a treatment option that can be
offered to older Veterans who want to discontinue hypnotics. This tapering program could help
VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine
discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce
the risk of falls and hip fractures, which ultimately may improve the health and quality of
life of older Veterans who receive healthcare at the VA.
Hypnotics such as benzodiazepines and benzodiazepine receptor agonists are often prescribed
for insomnia. Among Veterans attending outpatient clinics, approximately one-quarter use
hypnotics (or bedtime alcohol). Hypnotics use is associated with an increased risk of falls
and worse cognition in older adults. Discontinuing hypnotics often attenuates or reverses
these negative effects, and the Department of Veterans Affairs (VA) has initiatives to reduce
hypnotic use among older adults. Current discontinuation strategies focus on tapering off the
hypnotic and/or treating insomnia symptoms. Common strategies include supervised gradual
taper (SGT), cognitive behavioral therapy targeting hypnotic withdrawal (CBT-HW), cognitive
behavioral therapy for insomnia (CBTI), and combination therapy (SGT+CBTI). Yet up to 40% of
patients eventually resume use of hypnotics with these strategies, suggesting that other
mechanisms need to be targeted to achieve and sustain high rates of non-use.
Objectives: 1) To assess the efficacy of a novel taper plus cognitive behavioral
therapy-augmented program on hypnotic discontinuation among older Veterans, 2) to determine
the impact of the the novel taper intervention on insomnia severity, 3) to assess the impact
of the novel taper intervention on participants' beliefs and expectancies for using hypnotics
to improve sleep quality and daytime function, and 4) to assess the efficacy of the novel
taper intervention on balance and cognition.
To achieve these objectives, we propose to conduct a randomized clinical trial in older
Veterans recruited from a single VA site. Veterans will undergo a 3-step screening process
(letter with opt-out card, telephone screen, and in-person screen). Eligible participants (N
= 132) will be randomized to 8 weeks of the novel taper intervention (CBTI+taper method A) or
CBTI+taper method B. Follow-up assessments will be conducted at post-treatment and 6-months.
Key 6-month outcomes will include hypnotic discontinuation and use (measured objectively
through lab testing and medical record review/state prescription monitoring database query,
and subjectively through sleep diary), insomnia severity, beliefs and expectations about
hypnotics, balance, and cognition.
This hypnotic discontinuation program could be an important tool to help older Veterans who
want to discontinue hypnotics to achieve this goal.
for insomnia. Among Veterans attending outpatient clinics, approximately one-quarter use
hypnotics (or bedtime alcohol). Hypnotics use is associated with an increased risk of falls
and worse cognition in older adults. Discontinuing hypnotics often attenuates or reverses
these negative effects, and the Department of Veterans Affairs (VA) has initiatives to reduce
hypnotic use among older adults. Current discontinuation strategies focus on tapering off the
hypnotic and/or treating insomnia symptoms. Common strategies include supervised gradual
taper (SGT), cognitive behavioral therapy targeting hypnotic withdrawal (CBT-HW), cognitive
behavioral therapy for insomnia (CBTI), and combination therapy (SGT+CBTI). Yet up to 40% of
patients eventually resume use of hypnotics with these strategies, suggesting that other
mechanisms need to be targeted to achieve and sustain high rates of non-use.
Objectives: 1) To assess the efficacy of a novel taper plus cognitive behavioral
therapy-augmented program on hypnotic discontinuation among older Veterans, 2) to determine
the impact of the the novel taper intervention on insomnia severity, 3) to assess the impact
of the novel taper intervention on participants' beliefs and expectancies for using hypnotics
to improve sleep quality and daytime function, and 4) to assess the efficacy of the novel
taper intervention on balance and cognition.
To achieve these objectives, we propose to conduct a randomized clinical trial in older
Veterans recruited from a single VA site. Veterans will undergo a 3-step screening process
(letter with opt-out card, telephone screen, and in-person screen). Eligible participants (N
= 132) will be randomized to 8 weeks of the novel taper intervention (CBTI+taper method A) or
CBTI+taper method B. Follow-up assessments will be conducted at post-treatment and 6-months.
Key 6-month outcomes will include hypnotic discontinuation and use (measured objectively
through lab testing and medical record review/state prescription monitoring database query,
and subjectively through sleep diary), insomnia severity, beliefs and expectations about
hypnotics, balance, and cognition.
This hypnotic discontinuation program could be an important tool to help older Veterans who
want to discontinue hypnotics to achieve this goal.
Inclusion Criteria:
Age >= 60 years
- Use of lorazepam, alprazolam, temazepam, clonazepam, and/or zolpidem for current or
prior insomnia symptoms more than 3 nights per week for at least 3 months
- Current or prior insomnia symptoms
- Available to attend weekly in-person sessions over 9 weeks
Exclusion Criteria:
High risk for complications in outpatient hypnotic discontinuation program:
- Seizure disorder
- Supratherapeutic/high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night).
Note that for individuals on > 1 of the targeted hypnotics, total baseline dose in
diazepam-equivalents will be calculated & if > 8 mg/night, individual will be
excluded.
- High risk of complicated withdrawal; benzodiazepine intoxication or current or past
symptoms of complicated benzodiazepine/alcohol withdrawal (e.g., seizure, delirium at
baseline)
- Polydrug use (e.g., chronic high dose opioids)
- Unable to keep study medications in secure location
- Evidence of prescription fraud (e.g., multiple prescriptions for same drug filled at
VA and non-VA pharmacies, diversion)
Discontinuation of hypnotic not appropriate:
- Study-targeted hypnotic used to treat another clinical condition (e.g., REM sleep
behavior disorder)
- Not willing to begin hypnotic discontinuation program
Poor candidate for CBTI:
- Presence of bipolar disorder
- Cognitive impairment (e.g., Mini-Mental State Examination < 24)
- Sleep/wake difficulty is better explained by another sleep disorder such as restless
legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake
disorders
- Untreated sleep-disordered breathing defined as:
Apnea-hypopnea index (AHI) > 30 AHI between 15 and 30 and daytime sleepiness (Epworth
Sleepiness Scale > 10)
- Medically/psychiatrically unstable (e.g., recent major hospitalization or planned
major surgery during the study; psychosis, suicidal, active alcohol/substance abuse
based on history and medical records)
- Unstable housing situation
We found this trial at
1
site
West Los Angeles, California 90073
Principal Investigator: Constance H Fung, MD MS
Phone: 310-268-4437
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