- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369245
Techniques for Activating Consciousness (TAC) for Outpatients With Moderate to Severe Alcohol Addiction (TAC-ADDICT)
Randomized Controlled Trial to Evaluate the Efficacy of Hypnosis and Learning Self-exercises for Outpatients With Moderate to Severe Alcohol Addiction
Many patients are considering the use of so-called "hypnosis" treatments in the field of addictions. However, these techniques lack sufficient levels of evidence with regard to the standards required by Evidence-Based Medicine.
In other domains, however, hypnosis has demonstrated an interesting level of evidence, particularly in pain management.
The investigators will focus on the "Techniques for Activating Consciousness" (TAC), which represent an optimized therapeutic approach derived from hypnotic therapy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claire FARINA, Dr
- Phone Number: +33 01 39 63 93 80
- Email: cfarina@ght78sud.fr
Study Contact Backup
- Name: Nadia YOUNES, Dr
- Email: nyounes@ght78sud.fr
Study Locations
-
-
-
Le Chesnay, France, 78150
- Hospital Versailles
-
Contact:
- Claire FARINA, MD
- Email: cfarina@ght78sud.fr
-
Contact:
- Nadia YOUNES, MD
- Email: nyounes@ght78sud.fr
-
Sèvres, France, 92310
- CH des 4 Villes
-
Contact:
- Oleg BYKHOVSKIY
- Email: o.bykhovskiy@ch4v.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients consulting for an alcohol-related addiction problem at the CSAPA of Versailles (sites in Versailles, Trappes, Rambouillet) or at the Centre Hospitalier des 4 Villes (day hospital or CSAPA in Sèvres)
- Patients must meet at least 4 of the 11 DSM-5 criteria (Annex 2), corresponding to moderate to severe addiction
- Patients must be affiliated with the French social security system
Exclusion Criteria:
- Refusal to participate
Decompensated psychiatric pathology contraindicating therapy:
- Presence at inclusion of delusional, dissociative, and/or persecutory symptoms
- Presence at inclusion of hypomanic or manic decompensation
- Severe cognitive impairment, evidenced by inability to perform the clock-drawing test (draw the clock face, place the numbers, and set the hands to 11:10)
- Adults legally protected under French law (deprivation of liberty, legal safeguard, guardianship, curatorship)
- Inability to understand French
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: TAC intervention
|
Patients receiving TAC (Techniques for Activating Consciousness) intervention in addition to standard care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The patient's ability to control alcohol consumption during outpatient follow-up in a CSAPA
Time Frame: 6 months
|
The main outcome measure will be the number of weeks to achieve the targeted goal between T0 (first consultation when the objective is set) and M6 (cumulative time).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Controlling addictive behavior in both groups
Time Frame: 12 months
|
Evaluation criteria for both groups:
|
12 months
|
|
Evaluation criteria for the TAC group
Time Frame: 12 months
|
Weekly self-reports (via electronic patient questionnaire) on the frequency of exercise practice, perceived effectiveness of TAC (Techniques for Activating Consciousness) on their addictive issues (VAS 0-10), and tolerance of TAC (Techniques for Activating Consciousness)
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P23/03 - TAC-ADDICT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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