Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03208855 |
| Other study ID # |
IRB00117179 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 31, 2017 |
| Est. completion date |
October 13, 2020 |
Study information
| Verified date |
January 2022 |
| Source |
Johns Hopkins University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Substance Use Disorders (SUDs) and insomnia are major public health concerns, and each are
independently linked to reduced quality of life, disability, and high healthcare costs.
Insomnia, characterized by difficulty initiating or maintaining sleep, or nonrestorative
sleep, is prevalent in 10% of the general population and is co-morbid in 70% of patients with
SUDs. Primary insomnia and SUDs are chronic, unremitting diseases and have a complex
bidirectional relationship. Insomnia symptoms may predate the onset of SUDs and may explain
high prevalence of self-treatment. Insomnia may also be a direct effect of intoxication,
withdrawal, or abstinence from the substance of abuse. Subjective and objective measures of
sleep disruption have been shown in various stages of abuse and recovery. Insomnia is the
most well documented predictor of substance use relapse. Treatment specifically targeting
chronic insomnia is essential for improved clinical outcomes. Although, chronic insomnia is a
well-established, modifiable risk factor, to our knowledge, there are no interdisciplinary
residential treatment programs that specifically treat chronic insomnia during acute SUDs
treatment. We propose that improved treatment of insomnia as part of a comprehensive
reinforcement-based outpatient treatment program will provide an efficient and cost effective
opportunity to improve standard outpatient SUD. Converging evidence suggests that
prophylactic CBT-I during SUD treatment may have short and long-term efficacy for sleep, and
improve attrition. In the proposed study, patients with co-morbid SUDs and insomnia will
engage in an 8-week group CBT-I (gCBT-I) program in addition to receiving treatment as usual
for SUDs. This study may provide new hope to effectively treat insomnia in SUD and lead to a
new standardization of outpatient care. We hypothesize that a CBT-I intervention can be
implemented as part of an evidence-based SUD treatment program within a residential facility.
Description:
Substance use disorders (SUDs) are a leading cause of global disease burden with significant
epidemiological and economic consequences. Sleep disturbances (i.e., difficulty initiating or
maintaining sleep) are nearly ubiquitous in individuals with SUDs and may arise from direct
effects of the substance or from withdrawal of the substance. Sleep disturbances are reported
in up to 70% of individuals entering both detoxification and early recovery programs and may
persist for months to years during abstinence. Objective and subjective measures of sleep
disturbances are among the best predictors of relapse. Treatment of insomnia (i.e.,
difficulty initiating or maintaining sleep, with significant daytime impairment) during early
recovery may improve relapse rates. Insomnia is a modifiable risk factor and responds to
psychological interventions. Given the abuse potential of many medications utilized for sleep
disturbances and the likelihood of drug-drug interactions over the course of detoxification,
a non-pharmacological approach to insomnia remains promising. To date, few studies have
evaluated non-pharmacological approaches to insomnia during early substance abuse recovery.
One study has evidenced improved self-reported sleep quality in men who were assigned to 2
weeks of daily progressive muscle relaxation training. Robust evidence indicates that
cognitive behavioral therapy for insomnia (CBT-I) is effective, and in fact is first line
treatment for primary insomnia. A preponderance of randomized controlled trials of CBT-I in
co-morbid populations suggests it is efficacious to address insomnia in context of ongoing
medical and psychiatric illnesses. Despite the possibility that treating insomnia may improve
relapse and attrition rates, and evidence that CBT-I is efficacious in improving sleep, there
is a dearth of empirical data regarding the prophylactic benefit of initiating CBT-I as part
of acute abstinence treatment. This study aims to test the feasibility of implementing a
non-pharmacological insomnia intervention for individuals at the Cornerstone clinic at the
Helping Up Mission, a residential SUD residential recovery program for men in Baltimore, MD.
Participants will be recruited from the Cornerstone clinic, an accredited behavioral health
clinic directed by Johns Hopkins faculty and staff, which provides evidence-based SUD
treatment to residents of the Helping Up Mission. CBT-I will be incorporated into the
outpatient reinforcement-based SUD treatment. The investigators hypothesize that
implementation of CBT-I during early SUD recovery is feasible and will lead to improved sleep
parameters and improved clinical outcomes compared with those receiving treatment as usual
(TAU). The investigators propose a proof of concept study which would first demonstrate
feasibility of administering CBT-I for individuals residing in a men's homeless shelter, and
will further evaluate the short- and long-term efficacy of CBT for insomnia in individuals
with SUDs. This investigation will provide important and novel information regarding
potential psychological interventions that may be incorporated into evidence-based SUD
treatment.
