Alcohol Use DisorderCCAPNCT07260149
Coordinated Care for Alcohol Problems
A study testing CCAP in people with Alcohol Use Disorder, run by Sangath.
Trial summary
Parallel group individually randomised controlled trial (RCT) with stratified (by severity of drinking problem) randomisation into intervention and control arms. Aim is to test the effectiveness and cost-effectiveness of Coordinated Care for Alcohol Problems (CCAP) for the whole spectrum of drinking problems in… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- CCAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,022 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scoring positive for problem drinking (≥ 8 on the AUDIT)
- Have been residing in Goa for more than 12 continuous preceding months as an indicator of stability of residence which would be required both for treatment delivery and completion of outcome evaluation.
- Language:
- For hazardous drinking (AUDIT score of 8-15), patients must be able to understand at least one of the local vernacular languages (Hindi or Konkani) or English. Patients must be able to read at least one of the local vernacular languages (Hindi or Marathi) or English.
- For harmful and dependent drinking (AUDIT score of >15), patients must be able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
- For hazardous drinking, patients must also have access to a personal smartphone with WhatsApp.
- For dependent drinking (AUDIT score of >19), patients must consent for home visits and must also be eligible for home detoxification as per structured detoxification protocol.
Who cannot join
- For hazardous drinking, patients with significant visual or hearing impairment will be ineligible due to the audio-visual nature of the intervention.
- For harmful and dependent drinking, patients with significant speech, hearing, or language impairment (as evident during screening) will be excluded as the intervention is primarily a 'talking treatment'.
- For patients who present to the PHC/CHC needing urgent medical attention (emergency treatment or in-patient admission), screening will be deferred until their condition is stable.
- Those who are alcohol dependent and do not meet the eligibility criteria for home detoxification as per protocol.
- Those who are alcohol dependent but are currently not drinking. As AUDIT covers a period of 12 months, it will also detect those who meet the criteria for alcohol dependence over the past 12 months but are currently abstinent (hence not eligible for detoxification).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Coordinated Care for Alcohol Problems (CCAP): a Randomised Controlled Trial From Goa, India
Parallel group individually randomised controlled trial (RCT) with stratified (by severity of drinking problem) randomisation into intervention and control arms. Aim is to test the effectiveness and cost-effectiveness of Coordinated Care for Alcohol Problems (CCAP) for the whole spectrum of drinking problems in primary care in Goa, India. Primary outcome is the drinking outcome of percentage days abstinent (PDA) at three months post randomisation. Secondary outcomes include drinking outcomes (PDA at six- and 12- months post-randomisation; percentage days heavy drinking (PDHD), intensity of drinking and remission) and drinking related outcomes (e.g., injuries, violence) at three-, six- and 12- months post- randomisation. Participants will include consenting adult (>18 years) men with drinking problems attending Primary Healthcare Centres (PHCs) and Community Healthcare Centres (CHCs) in Goa and have drinking problems defined as scoring >8 on the Alcohol Use Disorder Identification Test (AUDIT). CCAP is a multi-component evidence-informed complex intervention package for coordinating treatment for all levels of problem drinking (hazardous, harmful, dependent). For hazardous drinking, it includes Mobile based Brief Intervention Treatment (M-BIT), which is a mobile-messaging brief intervention delivered via WhatsApp over eight weeks using multimedia content including contextually relevant messages, images and videos. For harmful drinking, it includes Counselling for Alcohol Problems Plus (CAP+) which is Counselling for Alcohol Problems (CAP), an evidence-based brief psychological treatment, integrated with strategies to enhance treatment engagement (entry into and completion). For dependent drinking, it includes Community Orientated Treatment for Alcohol Dependence (CONTAD) which is supervised home-detoxification over a week followed by a psychological treatment to prevent relapse, both integrated with treatment engagement strategies. CAP+ and CONTAD will be delivered in the community by non-specialist health workers (NSHW).
- Conditions
- Alcohol Use Disorder
- Being tested
- CCAP, Enhanced usual care
- Keywords
- Alcohol use disorder, Coordinated care, Complex intervention, Digital intervention, Psychosocial intervention, Non-specialist health workers, Task-sharing, Randomised controlled trial, India
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCAPBehavioural
Hazardous drinking: The content of the intervention includes seven themes: health education, alcohol reduction, drinking and risk management, drinking alternatives, situational content, urge management, and relapse prevention. Participants will receive texts and video-based messages building their awareness about drinking and associated harms.
Harmful drinking: CAP has three phases which are delivered in one to four sessions over six to eight weeks by NSHWs. Each session lasts between 30 to 45 minutes. The content is delivered through motivational interviewing with additional behavioural and cognitive components. CAP+ will include treatment engagement strategies integrated into CAP.
Dependent drinking: Home detoxification will be supervised by a doctor and monitored by the NSHW and a designated carer (e.g. spouse) for the patient at their home-setting. The counselling sessions are delivered by NSHWs, over 4-8 weeks and lasting 30-60 minutes each.
Enhanced usual careBehavioural
Hazardous drinking: An information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking.
Harmful drinking: CAP psychological brief treatment delivered by trained NSHWs (described above in detail).
Dependent drinking: Hospital-based detoxification delivered in secondary or tertiary care.
| Study group | Role | What they receive |
|---|---|---|
| CCAP | Experimental | Hazardous drinking: M-BIT is an eight-week digital intervention delivered over WhatsApp.
Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. CAP+ will include treatment engagement strategies integrated into CAP.
Dependent drinking: CONTAD is a manualised treatment comprising of 5-7 days of supervised home detoxification followed by relapse prevention counselling for dependent drinking.
Participants with harmful and dependent drinking level will be offered referral to the public District Hospitals or the state Psychiatric Hospital for assessment of eligibility for anti-craving medicines if available and to be prescribed and dispensed as per their Standard Operating Procedures. Receives: Behavioral: CCAP |
| Enhanced usual care | Active comparator | Hazardous drinking: Brief intervention leaflet which is an information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking.
Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. It has three phases which are delivered in one to four sessions over six to eight weeks by NSHWs. Each session lasts between 30 to 45 minutes. The content is delivered through motivational interviewing with additional behavioural and cognitive components. CAP has proven to be effective and cost-effective in reducing drinking in men with harmful level of drinking in a prior study. CAP can be delivered in any of the local vernacular (Hindi, Marathi, Konkani) or English.
Dependent drinking: Supported in-patient detoxification which is hospital-based detoxification delivered in secondary or tertiary care. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage days abstinent (PDA) [Parent trial]
Proportion of days abstinent in the past two weeks measured using the Timeline Follow Back (TLFB)
Measured: 3 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Number of heavy drinking days in the past two weeks measured using the TLFB
Measured: 3 months post randomisation
Treatment completion [Sub-group B Harmful Drinking]
Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following
- Received all sessions as per protocol
- Discharge by mutual agreement between NSHW and participant on achievement of treatment goals
- Referral out of the study
Measured: Through the period of intervention delivery, an average of 3 months
Intensity of drinking [Sub-group C Dependent drinking]
Units of alcohol consumed in the past week measured using the TLFB
Measured: 3 months post randomisation
Secondary outcomes (69)
Percentage days abstinent (PDA) [Parent trial]
Proportion of days abstinent in the past two weeks measured using the Timeline Follow
Measured: 6 months post randomisation
Percentage days abstinent (PDA) [Parent trial]
Proportion of days abstinent in the past two weeks measured using the Timeline Follow
Measured: 12 months post randomisation
Consequences of alcohol use [Parent trial]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 3 months post randomisation
Consequences of alcohol use [Parent trial]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 6 months post randomisation
Consequences of alcohol use [Parent trial]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 12 months post randomisation
Food security [Parent trial]
Improvement of food security as measured using Food Insecurity Experience Scale
Measured: 12 months post randomisation
Pattern of drinking [Parent trial]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 3 months post randomisation
Pattern of drinking [Parent trial]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 6 months post randomisation
Pattern of drinking [Parent trial]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 12 months post randomisation
Intensity of drinking [Parent trial]
Grams ethanol consumed per drinking day in the past two weeks measured using the TLFB
Measured: 3 months post randomisation
Intensity of drinking [Parent trial]
Grams ethanol consumed per drinking day in the past two weeks measured using the TLFB
Measured: 6 months post randomisation
Intensity of drinking [Parent trial]
Grams ethanol consumed per drinking day in the past two weeks measured using the TLFB
Measured: 12 months post randomisation
Remission [Parent trial]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 3 months post randomisation
Remission [Parent trial]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 6 months post randomisation
Remission [Parent trial]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 12 months post randomisation
System-level costs [Parent trial]
Economic costs in WHO six building blocks for delivering the interventions measured using inventory form for collecting system-level economic costs of delivering interventions (finance records and individuals involved in delivery of interventions)
Measured: Monthly, during the period of implementation
Out-of-pocket costs 1 [Parent trial]
Out-of-pocket costs for receiving general medical care and the related non-medical costs (e.g.: time loss, travel, etc) measured using Client Service Receipt Inventory form for collecting costs to patients who receive CCAP interventions
Measured: 3 months post randomisation
Out-of-pocket costs 1 [Parent trial]
Out-of-pocket costs for receiving general medical care and the related non-medical costs (e.g.: time loss, travel, etc) measured using Client Service Receipt Inventory form for collecting costs to patients who receive CCAP interventions
Measured: 6 months post randomisation
Out-of-pocket costs 1 [Parent trial]
Out-of-pocket costs for receiving general medical care and the related non-medical costs (e.g.: time loss, travel, etc) measured using Client Service Receipt Inventory form for collecting costs to patients who receive CCAP interventions
Measured: 12 months post randomisation
Out-of-pocket costs 2 [Parent trial]
Out-of-pocket costs for receiving CCAP interventions (e.g.: time loss, travel, etc) using survey form for receiving the CCAP interventions to patients who receive CCAP interventions
Measured: 3 months post randomisation
Out-of-pocket costs 2 [Parent trial]
Out-of-pocket costs for receiving CCAP interventions (e.g.: time loss, travel, etc) using survey form for receiving the CCAP interventions to patients who receive CCAP interventions
Measured: 6 months post randomisation
Out-of-pocket costs 2 [Parent trial]
Out-of-pocket costs for receiving CCAP interventions (e.g.: time loss, travel, etc) using survey form for receiving the CCAP interventions to patients who receive CCAP interventions
Measured: 12 months post randomisation
Disability [Parent trial]
Standardised disability scores used to estimate Quality-Adjusted Life Years (QALYs) using the WHO Disability Assessment Scale (WHODAS)
Measured: 3 months post randomisation
Disability [Parent trial]
Standardised disability scores used to estimate Quality-Adjusted Life Years (QALYs) using the WHO Disability Assessment Scale (WHODAS)
Measured: 6 months post randomisation
Disability [Parent trial]
Standardised disability scores used to estimate Quality-Adjusted Life Years (QALYs) using the WHO Disability Assessment Scale (WHODAS)
Measured: 12 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Number of heavy drinking days in the past two weeks measured using the TLFB
Measured: 6 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Number of heavy drinking days in the past two weeks measured using the TLFB
Measured: 12 months post randomisation
Intensity of drinking [Sub-group A Hazardous drinking]
Grams ethanol consumed per drinking day in past two weeks measured using the TLFB
Measured: 3 months post randomisation
Intensity of drinking [Sub-group A Hazardous drinking]
Grams ethanol consumed per drinking day in past two weeks measured using the TLFB
Measured: 6 months post randomisation
Intensity of drinking [Sub-group A Hazardous drinking]
Grams ethanol consumed per drinking day in past two weeks measured using the TLFB
Measured: 12 months post randomisation
Remission [Sub-group A Hazardous drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 3 months post randomisation
Remission [Sub-group A Hazardous drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 6 months post randomisation
Remission [Sub-group A Hazardous drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 12 months post randomisation
Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]
Proportion of days abstinent in the past two weeks measured using the TLFB
Measured: 3 months post randomisation
Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]
Proportion of days abstinent in the past two weeks measured using the TLFB
Measured: 6 months post randomisation
Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]
Proportion of days abstinent in the past two weeks measured using the TLFB
Measured: 12 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 3 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 6 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 12 months post randomisation
Treatment entry [Sub-group B Harmful drinking]
Proportion of consented participants who receive at least one session of counselling
Measured: 3 months post randomisation
Treatment entry [Sub-group B Harmful drinking]
Proportion of consented participants who receive at least one session of counselling
Measured: 6 months post randomisation
Treatment entry [Sub-group B Harmful drinking]
Proportion of consented participants who receive at least one session of counselling
Measured: 12 months post randomisation
Percentage days abstinent (PDA) [Sub-group B Harmful drinking]
Proportion of days abstinent in the past two weeks measured using the TLFB
Measured: 3 months post randomisation
Percentage days abstinent (PDA) [Sub-group B Harmful drinking]
Proportion of days abstinent in the past two weeks measured using the TLFB
Measured: 6 months post randomisation
Percentage days abstinent (PDA) [Sub-group B Harmful drinking]
Proportion of days abstinent in the past two weeks measured using the TLFB
Measured: 12 months post randomisation
Pattern of drinking [Sub-group B Harmful drinking]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 3 months post randomisation
Pattern of drinking [Sub-group B Harmful drinking]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 6 months post randomisation
Pattern of drinking [Sub-group B Harmful drinking]
Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB
Measured: 12 months post randomisation
Intensity of drinking [Sub-group B Harmful drinking]
Grams ethanol consumed per drinking day in past two weeks measured using the TLFB
Measured: 3 months post randomisation
Intensity of drinking [Sub-group B Harmful drinking]
Grams ethanol consumed per drinking day in past two weeks measured using the TLFB
Measured: 6 months post randomisation
Intensity of drinking [Sub-group B Harmful drinking]
Grams ethanol consumed per drinking day in past two weeks measured using the TLFB
Measured: 12 months post randomisation
Remission [Sub-group B Harmful drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 3 months post randomisation
Remission [Sub-group B Harmful drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 6 months post randomisation
Remission [Sub-group B Harmful drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 12 months post randomisation
Consequences of alcohol use [Sub-group B Harmful drinking]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 3 months post randomisation
Consequences of alcohol use [Sub-group B Harmful drinking]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 6 months post randomisation
Consequences of alcohol use [Sub-group B Harmful drinking]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 12 months post randomisation
Food security [Sub-group B Harmful drinking]
Improvement of food security as measured using Food Insecurity Experience Scale
Measured: 12 months post randomisation
Intensity of drinking [Sub-group C Dependent drinking]
Units of alcohol consumed in the past week measured using TLFB
Measured: 6 months post randomisation
Intensity of drinking [Sub-group C Dependent drinking]
Units of alcohol consumed in the past week measured using TLFB
Measured: 12 months post randomisation
Consequences of alcohol use [Sub-group C Dependent drinking]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 3 months post randomisation
Consequences of alcohol use [Sub-group C Dependent drinking]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 6 months post randomisation
Consequences of alcohol use [Sub-group C Dependent drinking]
Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP)
Measured: 12 months post randomisation
Food security [Sub-group C Dependent drinking]
Improvement of food security as measured using Food Insecurity Experience Scale
Measured: 12 months post randomisation
Remission [Sub-group C Dependent drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 3 months post randomisation
Remission [Sub-group C Dependent drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 6 months post randomisation
Remission [Sub-group C Dependent drinking]
Alcohol Use Disorder Identification Test (AUDIT) score <8
Measured: 12 months post randomisation
Treatment entry [Sub-group C Dependent drinking]
Proportion of consented participants who receive at least one session of counselling
Measured: Through the period of intervention delivery, an average of 3 months
Treatment completion [Sub-group C Dependent drinking]
Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following
- Received all sessions as per protocol
- Discharge by mutual agreement between NSHW and participant on achievement of treatment goals
- Referral out of the program
Measured: Through the period of intervention delivery, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Jun 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,022 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sangath
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260149
- Sponsor's protocol ID
- AN_2025_119
- Acronym
- CCAP
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Care for Alcohol Problems (CCAP): a Randomised Controlled Trial From Goa, India
- ClinicalTrials.gov ID
- NCT07260149
- Acronym / sponsor ID
- CCAP / AN_2025_119
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol use disorder, Coordinated care, Complex intervention, Digital intervention, Psychosocial intervention, Non-specialist health workers, Task-sharing, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,022 participants (estimated)
- Lead sponsor
- SangathUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parallel group individually randomised controlled trial (RCT) with stratified (by severity of drinking problem) randomisation into intervention and control arms. Aim is to test the effectiveness and cost-effectiveness of Coordinated Care for Alcohol Problems (CCAP) for the whole spectrum of drinking problems in primary care in Goa, India. Primary outcome is the drinking outcome of percentage days abstinent (PDA) at three months post randomisation. Secondary outcomes include drinking outcomes (PDA at six- and 12- months post-randomisation; percentage days heavy drinking (PDHD), intensity of drinking and remission) and drinking related outcomes (e.g., injuries, violence) at three-, six- and 12- months post- randomisation. Participants will include consenting adult (>18 years) men with drinking problems attending Primary Healthcare Centres (PHCs) and Community Healthcare Centres (CHCs) in Goa and have drinking problems defined as scoring >8 on the Alcohol Use Disorder Identification Test (AUDIT). CCAP is a multi-component evidence-informed complex intervention package for coordinating treatment for all levels of problem drinking (hazardous, harmful, dependent). For hazardous drinking, it includes Mobile based Brief Intervention Treatment (M-BIT), which is a mobile-messaging brief intervention delivered via WhatsApp over eight weeks using multimedia content including contextually relevant messages, images and videos. For harmful drinking, it includes Counselling for Alcohol Problems Plus (CAP+) which is Counselling for Alcohol Problems (CAP), an evidence-based brief psychological treatment, integrated with strategies to enhance treatment engagement (entry into and completion). For dependent drinking, it includes Community Orientated Treatment for Alcohol Dependence (CONTAD) which is supervised home-detoxification over a week followed by a psychological treatment to prevent relapse, both integrated with treatment engagement strategies. CAP+ and CONTAD will be delivered in the community by non-specialist health workers (NSHW).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCAP | Experimental | Behavioral: CCAPHazardous drinking: M-BIT is an eight-week digital intervention delivered over WhatsApp. Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. CAP+ will include treatment engagement strategies integrated into CAP. Dependent drinking: CONTAD is a manualised treatment comprising of 5-7 days of supervised home detoxification followed by relapse prevention counselling for dependent drinking. Participants with harmful and dependent drinking level will be offered referral to the public District Hospitals or the state Psychiatric Hospital for assessment of eligibility for anti-craving medicines if available and to be prescribed and dispensed as per their Standard Operating Procedures. |
| Enhanced usual care | Active comparator | Behavioral: Enhanced usual careHazardous drinking: Brief intervention leaflet which is an information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking. Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. It has three phases which are delivered in one to four sessions over six to eight weeks by NSHWs. Each session lasts between 30 to 45 minutes. The content is delivered through motivational interviewing with additional behavioural and cognitive components. CAP has proven to be effective and cost-effective in reducing drinking in men with harmful level of drinking in a prior study. CAP can be delivered in any of the local vernacular (Hindi, Marathi, Konkani) or English. Dependent drinking: Supported in-patient detoxification which is hospital-based detoxification delivered in secondary or tertiary care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scoring positive for problem drinking (≥ 8 on the AUDIT)
- Have been residing in Goa for more than 12 continuous preceding months as an indicator of stability of residence which would be required both for treatment delivery and completion of outcome evaluation.
- Language:
- For hazardous drinking, patients must also have access to a personal smartphone with WhatsApp.
- For dependent drinking (AUDIT score of >19), patients must consent for home visits and must also be eligible for home detoxification as per structured detoxification protocol.
Key exclusion criteria (5 listed)
- For hazardous drinking, patients with significant visual or hearing impairment will be ineligible due to the audio-visual nature of the intervention.
- For harmful and dependent drinking, patients with significant speech, hearing, or language impairment (as evident during screening) will be excluded as the intervention is primarily a 'talking treatment'.
- For patients who present to the PHC/CHC needing urgent medical attention (emergency treatment or in-patient admission), screening will be deferred until their condition is stable.
- Those who are alcohol dependent and do not meet the eligibility criteria for home detoxification as per protocol.
- Those who are alcohol dependent but are currently not drinking. As AUDIT covers a period of 12 months, it will also detect those who meet the criteria for alcohol dependence over the past 12 months but are currently abstinent (hence not eligible for detoxification).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCAPHazardous drinking: The content of the intervention includes seven themes: health education, alcohol reduction, drinking and risk management, drinking alternatives, situational content, urge management, and relapse prevention. Participants will receive texts and video-based messages building their awareness about drinking and associated harms. Harmful drinking: CAP has three phases which are delivered in one to four sessions over six to eight weeks by NSHWs. Each session lasts between 30 to 45 minutes. The content is delivered through motivational interviewing with additional behavioural and cognitive components. CAP+ will include treatment engagement strategies integrated into CAP. Dependent drinking: Home detoxification will be supervised by a doctor and monitored by the NSHW and a designated carer (e.g. spouse) for the patient at their home-setting. The counselling sessions are delivered by NSHWs, over 4-8 weeks and lasting 30-60 minutes each. | Behavioural | CCAP |
| Enhanced usual careHazardous drinking: An information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking. Harmful drinking: CAP psychological brief treatment delivered by trained NSHWs (described above in detail). Dependent drinking: Hospital-based detoxification delivered in secondary or tertiary care. | Behavioural | Enhanced usual care |
Primary outcome
Percentage days abstinent (PDA) [Parent trial]
Time frame: 3 months post randomisation
Proportion of days abstinent in the past two weeks measured using the Timeline Follow Back (TLFB)
Pattern of drinking [Sub-group A Hazardous drinking]
Time frame: 3 months post randomisation
Number of heavy drinking days in the past two weeks measured using the TLFB
Treatment completion [Sub-group B Harmful Drinking]
Time frame: Through the period of intervention delivery, an average of 3 months
Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following 1. Received all sessions as per protocol 2. Discharge by mutual agreement between NSHW and participant on achievement of treatment goals 3. Referral out of the study
Intensity of drinking [Sub-group C Dependent drinking]
Time frame: 3 months post randomisation
Units of alcohol consumed in the past week measured using the TLFB
69 secondary outcomes
Percentage days abstinent (PDA) [Parent trial]
Time frame: 6 months post randomisation
Percentage days abstinent (PDA) [Parent trial]
Time frame: 12 months post randomisation
Consequences of alcohol use [Parent trial]
Time frame: 3 months post randomisation
Consequences of alcohol use [Parent trial]
Time frame: 6 months post randomisation
Consequences of alcohol use [Parent trial]
Time frame: 12 months post randomisation
Food security [Parent trial]
Time frame: 12 months post randomisation
Pattern of drinking [Parent trial]
Time frame: 3 months post randomisation
Pattern of drinking [Parent trial]
Time frame: 6 months post randomisation
Pattern of drinking [Parent trial]
Time frame: 12 months post randomisation
Intensity of drinking [Parent trial]
Time frame: 3 months post randomisation
Intensity of drinking [Parent trial]
Time frame: 6 months post randomisation
Intensity of drinking [Parent trial]
Time frame: 12 months post randomisation
Remission [Parent trial]
Time frame: 3 months post randomisation
Remission [Parent trial]
Time frame: 6 months post randomisation
Remission [Parent trial]
Time frame: 12 months post randomisation
System-level costs [Parent trial]
Time frame: Monthly, during the period of implementation
Out-of-pocket costs 1 [Parent trial]
Time frame: 3 months post randomisation
Out-of-pocket costs 1 [Parent trial]
Time frame: 6 months post randomisation
Out-of-pocket costs 1 [Parent trial]
Time frame: 12 months post randomisation
Out-of-pocket costs 2 [Parent trial]
Time frame: 3 months post randomisation
Out-of-pocket costs 2 [Parent trial]
Time frame: 6 months post randomisation
Out-of-pocket costs 2 [Parent trial]
Time frame: 12 months post randomisation
Disability [Parent trial]
Time frame: 3 months post randomisation
Disability [Parent trial]
Time frame: 6 months post randomisation
Disability [Parent trial]
Time frame: 12 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Time frame: 6 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Time frame: 12 months post randomisation
Intensity of drinking [Sub-group A Hazardous drinking]
Time frame: 3 months post randomisation
Intensity of drinking [Sub-group A Hazardous drinking]
Time frame: 6 months post randomisation
Intensity of drinking [Sub-group A Hazardous drinking]
Time frame: 12 months post randomisation
Remission [Sub-group A Hazardous drinking]
Time frame: 3 months post randomisation
Remission [Sub-group A Hazardous drinking]
Time frame: 6 months post randomisation
Remission [Sub-group A Hazardous drinking]
Time frame: 12 months post randomisation
Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]
Time frame: 3 months post randomisation
Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]
Time frame: 6 months post randomisation
Percentage days abstinent (PDA) [Sub-group A Hazardous drinking]
Time frame: 12 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Time frame: 3 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Time frame: 6 months post randomisation
Pattern of drinking [Sub-group A Hazardous drinking]
Time frame: 12 months post randomisation
Treatment entry [Sub-group B Harmful drinking]
Time frame: 3 months post randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing CCAP in people with Alcohol Use Disorder, run by Sangath.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abhijit Nadkarni (+91 7887872345, abhijit.nadkarni@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage days abstinent (PDA) [Parent trial] (time frame: 3 months post randomisation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.