The Effect of Family History on Insomnia During Sobriety in Alcoholics

Insomnia Clinical Trial

Official title:

The Effect of Family History on Insomnia During Sobriety in Alcoholics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603381
• Other study ID #: 01257
• Status: Completed
• Phase: N/A
• First received: February 3, 2012
• Last updated: October 2, 2016
• Start date: June 2012
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Corporal Michael J. Crescenz VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The investigators intend to assess the following:

• the efficacy of CBTi in treating insomnia during recovery,

• does a family history of alcoholism moderate the insomnia symptoms,

• does an improvement in insomnia lead to a decrease in impulsivity.

Description:

The primary goals of this pilot study are the following:

a) to assess for the difference in improvement insomnia, after 8 weeks of treatment with recommended CBTi, in Veterans with alcohol dependence during early recovery,

The secondary goals include the following:

1. to assess for any change in the alcohol consumption indices between the groups after 8 weeks of CBTi,

2. to assess for change in psychiatric symptoms of mood and anxiety across the groups,

3. to assess for differences in insomnia in subjects, with and without a first degree family history of alcohol dependence,

4. to evaluate for any change in impulsivity-related measure with insomnia treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Presence of insomnia currently

2. DSM IV diagnosis of alcohol dependence within the past year

3. Not in acute alcohol withdrawal and within a year of sobriety from alcoholism

4. Patients with moderate-severe sleep apnea compliant on their PAP device

5. Can speak, understand and print in English.

6. Is capable of giving written informed consent.

Exclusion Criteria:

1. Dependence on psychoactive substance (excluding alcohol, nicotine and cannabis) in the past 12 months, or evidence of chronic opiate use.

2. Unstable/serious psychiatric condition e.g. schizophrenia, bipolar disorder.

3. Unstable or serious medical/neurologic illness

4. Severe cognitive impairment

5. Untreated moderate - severe obstructive sleep apnea

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia (CBT-I)
Behavioral management of insomnia

Locations

Country	Name	City	State
United States	Philadelphia Veterans Affairs Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Corporal Michael J. Crescenz VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index total score	There will be post-treatment follow up at 3 months and 6 months.	8 weeks.	No
Secondary	Time Line Follow Back measure	There will be post-study follow-up at 3 months and 6 months also.	8 weeks.	No