Alcohol Use DisorderNCT03988478
Inpatient Alcohol Detox & Psychotherapy
A study testing Detoxification & psychotherapeutic support in people with Alcohol Use Disorder, run by Tribhuvan University, Nepal.
Trial summary
The aim of the study is to evaluate effectiveness of inpatient detoxification and psycho-therapeutic support, measured in terms of readiness to change and abstinence maintenance. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Detoxification & psychotherapeutic support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 25 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as ADS according to ICD 10
Who cannot join
- Major Psychiatric or medical comorbidity
About this study
Official title: Effectiveness of Inpatient Alcohol Detoxification and Psychotherapeutic Support Program
The aim of the study is to evaluate effectiveness of inpatient detoxification and psycho-therapeutic support, measured in terms of readiness to change and abstinence maintenance. The study participants will be the patients admitted for alcohol use disorder (age: 18 years above) at a tertiary level hospital in Kathmandu. Baseline assessments on readiness to change will be done during admission, and compared prior to and after discharge. Percentage of participants maintaining abstinence in 3 months after discharge will be another outcome to be analysed.
- Conditions
- Alcohol Use Disorder
- Being tested
- Detoxification & psychotherapeutic support
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detoxification & psychotherapeutic supportBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Behavioral, detoxificaiton & psychotherapy | Experimental | Providing treatment as usual (detoxificaion) \& psychotherapy Receives: Behavioral: Detoxification & psychotherapeutic support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
The questionnaire is 19 item self-report questionnaire assessing client readiness for change. There are three sub scales: Recognition, Ambivalence, and Taking Steps. Higher scores indicate greater recognition, ambivalence and taking steps. Scores range from 7 to 35, 4 to 20, and 8-40, respectively.
Measured: Change from baseline at discharge, an average of 2 weeks
Percentage of participants staying abstinent
Percentage of participants not taking single drink or staying complete abstinent
Measured: Three month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Jan 2017
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tribhuvan University, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jugu Maya Chaudhary, Tribhuvan University, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988478
- Sponsor's protocol ID
- DOPMH-Inpt-detox-Psychotherapy
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If required, it will be discussed among the team and will be decided on need basis
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Inpatient Alcohol Detoxification and Psychotherapeutic Support Program
- ClinicalTrials.gov ID
- NCT03988478
- Acronym / sponsor ID
- DOPMH-Inpt-detox-Psychotherapy
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Tribhuvan University, NepalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 17 Jun 2019 (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.
The aim of the study is to evaluate effectiveness of inpatient detoxification and psycho-therapeutic support, measured in terms of readiness to change and abstinence maintenance. The study participants will be the patients admitted for alcohol use disorder (age: 18 years above) at a tertiary level hospital in Kathmandu. Baseline assessments on readiness to change will be done during admission, and compared prior to and after discharge. Percentage of participants maintaining abstinence in 3 months after discharge will be another outcome to be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral, detoxificaiton & psychotherapy | Experimental | Behavioral: Detoxification & psychotherapeutic supportProviding treatment as usual (detoxificaion) \& psychotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed as ADS according to ICD 10
Key exclusion criteria (1 listed)
- Major Psychiatric or medical comorbidity
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 |
|---|---|---|
| Detoxification & psychotherapeutic support | Behavioural | Behavioral, detoxificaiton & psychotherapy |
Primary outcome
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form
Time frame: Change from baseline at discharge, an average of 2 weeks
The questionnaire is 19 item self-report questionnaire assessing client readiness for change. There are three sub scales: Recognition, Ambivalence, and Taking Steps. Higher scores indicate greater recognition, ambivalence and taking steps. Scores range from 7 to 35, 4 to 20, and 8-40, respectively.
Percentage of participants staying abstinent
Time frame: Three month follow up
Percentage of participants not taking single drink or staying complete abstinent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Individual participant dataSharing planned: Undecided. If required, it will be discussed among the team and will be decided on need basis
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Detoxification & psychotherapeutic support in people with Alcohol Use Disorder, run by Tribhuvan University, Nepal.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jun 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) Short Form (time frame: Change from baseline at discharge, an average of 2 weeks). The study lists 2 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 17 Jun 2019.