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Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder

Primary Purpose

Stress Disorders, Post-Traumatic, Alcohol Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Propranolol
Placebo
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults between 18 and 70 years old inclusively Diagnosed with AUD in the past year (according to the Structured Clinical Interview for DSM-5 (SCID)25). This will include active drinkers and recently abstained drinkers. has a minimum of two episodes of heavy drinking (≥5 drinks in a single day for men and ≥4 drinks in a single day for women) in the past 30 days as used in other trials26 Diagnosed with current (past 30 days) PTSD with the Clinician- Administered PTSD Scale for DSM-5 (CAPS-5) on screening27 On an antidepressant as treatment of PTSD (to ensure safety and homogeneity as PTSD treatment of study population). Antidepressants are the first-line treatment for PTSD as well major depression which commonly comorbid PTSD. The presence of antidepressants in study recruitment criteria will ensure additional safety if the trauma focused therapy triggered emotional distress which could temporarily activate depressive symptoms. The presence of antidepressants in all study participants will also ensure proper evaluation of the effect of propranolol without any confounders effect. Agrees (if the participant is female and of childbearing potential) to use at least one of the following highly effective methods of contraception, such as hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or alternatively double barrier method. Agrees not to start any other therapy including self-help group during the trial period. Exception will be made for participants who had already started therapy and have been attending the sessions for at least 6 months. Agrees not to start any anti-craving medications for alcohol use during the trial period. Exception will be made for participants who were already taking an anti-craving medication for at least 6 months. Able to speak and read in English Exclusion Criteria: Diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per study physician, including contraindications to propranolol administration such as asthma, diabetes, arrhythmia or congestive heart failure Diagnosed with psychotic disorder or bipolar disorder The use of alcohol abstinence medications within the past month Current moderate or severe substance use disorder (excluding alcohol, cannabis, tobacco and caffeine) A basal systolic blood pressure < 100 mm Hg or basal heart rate < 55 beats/minute Pregnant or breastfeeding women Individuals with known hypersensitivity to propranolol Individuals with current use of medication that might interact adversely with propranolol such as anti-arrhythmic medication or calcium channel blockers Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes"28 Any participant known to have non-allergic bronchospasm such as chronic bronchitis, emphysema, bronchiectasis, hypotension, metabolic acidosis, severe peripheral arterial circulatory disturbance, untreated phaeochromocytoma, Prinzmetal's angina Any participant with known hypersensitivity to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Any participant using catecholamine depletion drugs such as reserpine or guanethidine.

Sites / Locations

  • CAMHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propranolol

Placebo

Arm Description

Medication treatment regimen will consist of 12 weeks of 40 mg immediate-release propranolol BID

Matching placebo will be administered BID for 12 weeks

Outcomes

Primary Outcome Measures

Number of CPT sessions attended
Number of CPT (therapy) sessions attended by participants

Secondary Outcome Measures

CAPS-5 total symptom severity score
PTSD symptoms measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores at baseline, midpoint (week-6) and endpoint (week 12); the CAPS-5 total symptom severity score is the sum of severity (rated 0-4) on 20 individual items, where a higher score indicates greater symptom severity
Number of drinks per week (TLFB)
Alcohol consumption to be monitored using the timeline follow-back (TLFB)
Percent heavy drinking days (TLFB)
Percent heavy drinking days will be measured weekly. A "heavy drinking day" will be defined as 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Alcohol craving
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS), which includes five items scored on a Likert scale from 0 to 6 Min score=0, max score=30, higher scores indicate greater craving

Full Information

First Posted
January 11, 2023
Last Updated
October 16, 2023
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT05692271
Brief Title
Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder
Official Title
Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the therapeutic tolerability of the use of Cognitive Processing Therapy (CPT) with propranolol in participants with Posttraumatic Stress Disorder (PTSD) and Alcohol Use Disorder (AUD). The investigators are planning to perform an initial proof -of- concept randomized, placebo- controlled trial evaluating propranolol in participants with PTSD and AUD starting CPT for 12 weeks with three post-treatment follow ups at week-16, week-20, and week-24. Participants with current diagnosis of PTSD and AUD seeking treatment will be randomized to either a propranolol group (n=24) or placebo group (n=24) after enrollment. All participants will receive CPT for 12 weeks after randomization. Primary outcomes will be measured in both groups at the end of the study (week 12).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propranolol
Arm Type
Experimental
Arm Description
Medication treatment regimen will consist of 12 weeks of 40 mg immediate-release propranolol BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo will be administered BID for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
40 mg teva-propranolol taken twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Number of CPT sessions attended
Description
Number of CPT (therapy) sessions attended by participants
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
CAPS-5 total symptom severity score
Description
PTSD symptoms measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores at baseline, midpoint (week-6) and endpoint (week 12); the CAPS-5 total symptom severity score is the sum of severity (rated 0-4) on 20 individual items, where a higher score indicates greater symptom severity
Time Frame
12 weeks
Title
Number of drinks per week (TLFB)
Description
Alcohol consumption to be monitored using the timeline follow-back (TLFB)
Time Frame
12 weeks
Title
Percent heavy drinking days (TLFB)
Description
Percent heavy drinking days will be measured weekly. A "heavy drinking day" will be defined as 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.
Time Frame
12 weeks
Title
Alcohol craving
Description
Alcohol craving will be assessed using the Penn Alcohol Craving Scale (PACS), which includes five items scored on a Likert scale from 0 to 6 Min score=0, max score=30, higher scores indicate greater craving
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults between 18 and 70 years old inclusively Diagnosed with AUD in the past year (according to the Structured Clinical Interview for DSM-5 (SCID)25). This will include active drinkers and recently abstained drinkers. has a minimum of two episodes of heavy drinking (≥5 drinks in a single day for men and ≥4 drinks in a single day for women) in the past 30 days as used in other trials26 Diagnosed with current (past 30 days) PTSD with the Clinician- Administered PTSD Scale for DSM-5 (CAPS-5) on screening27 On an antidepressant as treatment of PTSD (to ensure safety and homogeneity as PTSD treatment of study population). Antidepressants are the first-line treatment for PTSD as well major depression which commonly comorbid PTSD. The presence of antidepressants in study recruitment criteria will ensure additional safety if the trauma focused therapy triggered emotional distress which could temporarily activate depressive symptoms. The presence of antidepressants in all study participants will also ensure proper evaluation of the effect of propranolol without any confounders effect. Agrees (if the participant is female and of childbearing potential) to use at least one of the following highly effective methods of contraception, such as hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or alternatively double barrier method. Agrees not to start any other therapy including self-help group during the trial period. Exception will be made for participants who had already started therapy and have been attending the sessions for at least 6 months. Agrees not to start any anti-craving medications for alcohol use during the trial period. Exception will be made for participants who were already taking an anti-craving medication for at least 6 months. Able to speak and read in English Exclusion Criteria: Diagnosed with a severe or unstable medical illness that precludes safe participation in the study as per study physician, including contraindications to propranolol administration such as asthma, diabetes, arrhythmia or congestive heart failure Diagnosed with psychotic disorder or bipolar disorder The use of alcohol abstinence medications within the past month Current moderate or severe substance use disorder (excluding alcohol, cannabis, tobacco and caffeine) A basal systolic blood pressure < 100 mm Hg or basal heart rate < 55 beats/minute Pregnant or breastfeeding women Individuals with known hypersensitivity to propranolol Individuals with current use of medication that might interact adversely with propranolol such as anti-arrhythmic medication or calcium channel blockers Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes"28 Any participant known to have non-allergic bronchospasm such as chronic bronchitis, emphysema, bronchiectasis, hypotension, metabolic acidosis, severe peripheral arterial circulatory disturbance, untreated phaeochromocytoma, Prinzmetal's angina Any participant with known hypersensitivity to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Any participant using catecholamine depletion drugs such as reserpine or guanethidine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Hassan, MD
Phone
416-535-8501
Ext
34051
Email
ahmed.hassan@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Justin Matheson, PhD
Phone
416-535-8501
Ext
34727
Email
justin.matheson@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hassan, MD
Organizational Affiliation
CAMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAMH
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Hassan, MD
Email
ahmed.hassan@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Testing a Novel Therapeutic Strategy for Comorbid Post-Traumatic Stress Disorder and Alcohol Use Disorder

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