Qi Gong as a Method of Craving Reduction in Severe Addict Patients

NCT03589118 | Unknown

• 2 other identifiers: P160946J2017-A02986-47
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 3

Brief Summary

Craving arises in response to an affective tone that is associated with perceptual representations of a sensory object, rather than directly in response to the object. The investigators presume that qi gong functions to decouple pleasant and unpleasant experience from habitual reactions by removing the affective bias that fuels such emotional reactivity. Qi gong training may specifically target the associated learning process with an emphasis on the critical link between affect and craving in an addictive loop.

Conditions

Alcohol Addiction; Alcohol Dependence

Keywords

Substance Addiction; Craving; Chinese Medecine; Qi Gong; Psychology

Outcome Measures

Primary Outcomes (1)

• Variation of craving intensity

  Variation of craving intensity on a Vvisual aAnalogic sScale (VAS) between baseline and the end of the treatment. The intensity is measured by "not at all" (score of 0) and "craving as bad as it could be" or "the most I've ever felt " (maximum score of 10), self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents his craving intensity. The score is determined by measuring the distance on the 10-cm line between the "no craving" anchor and the patient's mark.

  Change in VAS from baseline to 9 weeks treatment

Secondary Outcomes (9)

• Evolution over time of craving intensity

  0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline

• Difference in treatment retention

  3 weeks and 9 weeks post-baseline

• Evolution over time of total alcohol consumption

  0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline

• Evoluation over time of anxiety

  0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline

• Evolution over time of depression

  0 day, 3 days, 5 days, 3 weeks and 9 weeks post-baseline

Study Arms (2)

Qi Gong

EXPERIMENTAL

Qi gong sessions added to usual well defined medical and psychological support

Other: Qi Gong sessions

Control

NO INTERVENTION

Usual well defined medical and psychological support

Interventions

Qi Gong sessions OTHER

13 sessions of Qi Gong in a 9 weeks period

Qi Gong

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM 5 criteria for alcohol use disorder and other substance use disorders
• Alcohol is one of the major abused substances if using multiple substances
• Severity of the disorder defines by the necessity of a complex withdrawal hospitalization.
• Used alcohol in the 3 weeks before hospitalization
• Seeks addiction treatment
• Patient willing to adhere to the study protocol (e.g. attend all visits and follow-ups in the next 3 months).
• Age ≥ 18
• Negative pregnancy test (βHCG) for women of child bearing potential
• Signed informed consent
• Affiliation to the French health insurance (recipient or assign)
• Oral and written comprehension of the french langage
• Pose a current suicidal risk including active suicidal ideation and suicide attempt in the past 30 days
• Non stabilized severe psychiatric comorbidities such as bipolar disorder, schizophrenia, … (at the investigator's discretion)
• Pregnant or breastfeeding women
• Decompensated cirrhosis, liver encephalopathy, neurological complications, severe cognitive impairment and any other severe somatic comorbidity (at the investigator's discretion)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Hôpital Saint ELOI

Montpellier, 34000, France

RECRUITING

Hôpital L'ARCHET

Nice, 06002, France

ACTIVE NOT RECRUITING

Groupe Hospitalier Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Alain BAUMELOU, MD, Ph.D

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Nathalie PLET, Ph.D

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Alain BAUMELOU, MD, Ph.D

CONTACT

01 42 16 05 75; alain.baumelou@aphp.fr

Nathalie PLET, Ph.D

CONTACT

01 42 16 05 75; nathalie.plet@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Primary outcome (VAS scale) will be presented to the patient and reported by a study nurse blinded of the randomization arm of the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomized in two groups : * usual medical and psychological support in the control group * qi gong sessions added in the experimental group Allocation between groups qi and control is 1 : 1

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: July 17, 2018
• Study Start: October 4, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 17, 2019

Record last verified: 2019-07

Locations

FR (3)