Novel treatments for alcohol dependence: A randomized controlled trial of structured stepped-care intervention for psychiatric comorbidity

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12607000039482
• Date of registration: 12/01/2007
• Prospective Registration: No
• Primary sponsor: University of Sydney
• Public title: Novel treatments for alcohol dependence: A randomized controlled trial of structured stepped-care intervention for psychiatric comorbidity
• Scientific title: Novel treatments for alcohol dependence: A randomized controlled trial of structured stepped-care intervention for psychiatric comorbidity to improve drinking outcomes and reduce comorbid mood or anxiety symptoms.
• Date of first enrolment: 01/04/2006
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12607000039482.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;

Countries of recruitment

Australia

Contacts

• Name: Paul Haber

• Name: Paul Haber

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria for step 1: (i) alcohol dependence according to DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders 4th edition), with alcohol as the subject’s drug of choice, (ii) adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination), (iii) willingness to give written consent, (iv) abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone), (v) resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC).
Entry criteria to step 2: (i) Completion of 3 weeks on acamprosate and/or natlrexone, (ii) resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), (iii) case formulation and diagnosis for anxiety or depression (see below).
Exclusion criteria: Exclusion criteria for step 1: (i) sensitivity to study medications or therapy with these drugs within 6 months, (ii) active major psychiatric disorder associated with significant suicide risk, (iii) pregnancy or lactation, (iv) advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy), (v) other serious medical illness that would interfere with adherence to the study protocol.
Exclusion criteria 2: (i) Non-compliance on acamprosate and/or naltrexone, (ii) alcohol consumption at baseline levels, (iii) resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment as appropriate within the service and continue to be monitored.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Anxiety

Mental Health - Addiction

Alcohol Dependence;
Alcohol Dependence

Intervention(s)

12-week intervention: Reduction and stabilisation of alcohol intake using pharmacotherapy (naltrexone, acamprosate or a combination of the two)followed by formal psychiatric assessment. Participants meeting criteria for psychiatric comorbidity will be randomised to receive manualised psychological therapy for comorbid psychiatric and alcohol problems.

Primary Outcome(s)

(ii) clinician rated severity from Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) and Hamilton DepressionRating Scale (HDRS) on anxiety and depressive diagnoses.[Measured at week 12 (post-treatment) and week 26 (follow-up)]

(i) time to relapse (>5 drinks on any one day)[Measured at week 12 (post-treatment) and week 26 (follow-up)]

Secondary Outcome(s)

(ii) self-reported amount of alcohol consumed, expressed as the average consumption per drinking day.[Measured at week 12 (post-treatment) and week 26 (follow-up).]

(i) time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption.[Measured at week 12 (post-treatment) and week 26 (follow-up).]

(v) episodes of alcohol related harm (psychosocial, occupational, forensic, medical).[Measured at week 12 (post-treatment) and week 26 (follow-up).]

(iii) improvement in depressive or anxiety symptoms (Depression Anxiety and Stress Scale; DASS-21).[Measured at week 12 (post-treatment) and week 26 (follow-up).]

(iv) biological markers of alcohol consumption at 6, 12 and 26 weeks (carbohydrate-deficient transferrin (CDT), Liver Function Tests (LFTs) and Mean Cell Volume (MCV)).[Measured at week 12 (post-treatment) and week 26 (follow-up).]

Source(s) of Monetary Support

Alcohol Education and Rehabilitation Fund

Secondary Sponsor(s)

Royal Prince Alfred Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Royal Prince Alfred Hospital

Status: Approved
Approval date:
Contact:

University of NSW

Status: Approved
Approval date:
Contact:

University of Sydney