New study about benzos/mindfulness

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Effectiveness of Mindfulness Based Relapse Prevention for Chronic Users of Benzodiazepines (MBRP)

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2014 by Federal University of São Paulo

Sponsor:

Federal University of São Paulo

Collaborators:

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by (Responsible Party):

Ana Regina Noto, Federal University of São Paulo

ClinicalTrials.gov Identifier:

NCT02127411

First received: March 10, 2014

Last updated: September 3, 2014

Last verified: September 2014

History of Changes

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  Purpose

Benzodiazepines (BZD) are the most prescribed psychiatric drugs in Brazil, especially for women. Although it is recommended that the use of BZD is not greater than four weeks, there are many cases of prolonged use due to the lack of treatment options for dealing with complaints of insomnia. Given this, the aim of this project is to evaluate the program Mindfulness-Based Relapse Prevention (MBRP) for adult women with chronic use of benzodiazepine (BZD) to induce sleep. Specifically aims to evaluate if the MBRP program, can reduce the pattern of use and level of dependence of chronic users of BZD under gradual reduction (tapering) or cessation of the use of BZD. This study will be conducted at the Drug Dependency Unit (UDED) of the Department of Psychobiology of Federal University of São Paulo. The study will count with two groups: intervention group (IG) and control group (CG) (that will stay in the waitlist until the eighth month . The sample will comprise 100 women with chronic use of BZD as hypnotics, 50 will be randomized in the IG condition and 50 in the CG condition. Changes will be evaluated on several variables such as cessation and dependence of BZD, quality of life, sleep, anxiety, depression and sexual satisfaction before and after the intervention in both groups. The data will be submitted to descriptive and inferential bivariate and multivariate statistic analyzes. It is hoped that this study create subsidies for the development of complementary interventions for the management of withdrawal symptoms in chronic users of BZD.

Condition

Intervention

Benzodiazepine Dependence

Behavioral: Mindfulness-Based Relapse Prevention

Study Type: Interventional 

Study Design: Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Open Label

Primary Purpose: Supportive Care

Official Title: Adaptation and Evaluation of the Mindfulness-Based Relapse Prevention Program for Cessation and/or Reduction of Benzodiazepine Chronic Use to Induce Sleep Among Women

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures: •reduction of benzodiazepine use [ Time Frame: Change from baseline in benzodiazepine use at 8 months. ] [ Designated as safety issue: No ]

We will evaluate the reduction through a percentual comparison between the dose the patient is using at follow-up assessments and the dose related at the beginning of the study.

Secondary Outcome Measures: •Stage of change related to benzodiazepine use [ Time Frame: Change from Baseline of the stage of change at 8 months ] [ Designated as safety issue: No ]

This will be measured by the University of Rhode Island Change Assessment (URICA) that categorizes the readiness to change of the participants in four stages: precontemplation, contemplation, action and maintenance.

•self report mindfulness level [ Time Frame: Change in mindfulness level from baseline at 8 months ] [ Designated as safety issue: No ]

This will be measured with the self report questionnaires: Mindful Attention Awareness Scale and Five Facet Mindfulness Questionnaire. Those are self-report questionnaires and do not have a specific metric to measure mindfulness. The scores are absolute and a higher score denotes higher levels of mindfulness

•Level of Benzodiazepine dependence (from mild to severe) [ Time Frame: change in benzodiazepine dependence severity from baseline at 8 months ] [ Designated as safety issue: No ]

this will be measured through the Benzodiazepine Dependence Self-Report Questionnaire, which is a self report questionnaire and do not provides a specific metric to measure the severity of dependence.

•Symptoms of depression [ Time Frame: Change in symptoms of depression from baseline at 8 months ] [ Designated as safety issue: No ]

The symptoms of depression will be measured through the Center for Epidemiologic Studies Depression Scale - CES-D. As it is a self report scale, there is no specific metric to measure depression.

•Quality of Life [ Time Frame: change in quality of life from baseline at 8 months ] [ Designated as safety issue: No ]

The quality of life will also be measured through a self-report questionnaire (Whoqol-Bref).

•Sleep Quality [ Time Frame: Change in sleep quality from baseline at 8 months ] [ Designated as safety issue: No ]

will be measured through the Pittsburgh Sleep Quality Index

•menopausal symptoms (Kupperman index) [ Time Frame: change in menopausal symptoms from baseline at 8 months ] [ Designated as safety issue: No ]

•Female Sexual Satisfaction [ Time Frame: change in female sexual satisfaction from baseline at 8 months ] [ Designated as safety issue: No ]

•presence of benzodiazepines metabolites identified with a toxicology urinalysis [ Time Frame: Change in benzodiazepine metabolites from baseline at eigh months ] [ Designated as safety issue: No ]

•Epigenetic modifications [ Time Frame: Baseline and 2 month follow-up ] [ Designated as safety issue: No ]

Blood collection will be held, and the plasma will be analyzed to evaluate levels of homocysteine and cysteine , two aminoacids that are related to epigenetic modifications that can modulate the behavioral responses resulting from the practice of meditation

Estimated Enrollment: 100

Study Start Date: October 2013

Estimated Study Completion Date: October 2017

Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Arms 

Assigned Interventions 

Experimental: Mindfulness-based relapse prevention

Mindfulness-Based Relapse Prevention

Behavioral: Mindfulness-Based Relapse Prevention

The MBRP is an adjuvant treatment for people that have been treated for drug use related problems

No Intervention: Waitlist

this group will stay in the waitlist until the end of follow-up assessments, when they will receive the intervention

  Eligibility

Ages Eligible for Study:    18 Years and older

Genders Eligible for Study:    Female

Accepts Healthy Volunteers:    No

Criteria

Inclusion Criteria:

•Literate adult women

•Using benzodiazepine (BZD) for inducing sleep for at least 03 months (90 days), for at least four times a week.

Exclusion Criteria:

•Having practiced regularly meditation, yoga or similar previously, at least once a week, for at least three months, or have carried this practice regularly at least once a week in the last year for at least one month

•Neurological disorders, anxiety refractory to other treatments or insomnia secondary to other severe clinical conditions, which the BZD withdrawal is considered as a potential risk for worsening

•Presence of not controlled clinical disease or of greater severity, such as cancer, schizophrenia, epilepsy

•Presence of psychiatric illness which withdrawal of BZD is considered a potential risk for worsening

•Dependence or abuse of alcohol or other drugs, except tobacco

•In acute treatment for psychological or psychiatric problems

•Be participating in a tapering BZD protocol, or similar

  Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02127411

Contacts

Contact: Víviam V Barros, Master 55 11 5549-2500 viviamvb@yahoo.com.br 

Locations

Brazil

Drug Dependency Unit of the Federal University of São Paulo (UDED) Recruiting

São Paulo, SP, Brazil 

Contact: Víviam V Barros, master      viviamvb@yahoo.com.br   

Principal Investigator: Víviam V Barros, master         

Sponsors and Collaborators

Federal University of São Paulo

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Fundação de Amparo à Pesquisa do Estado de São Paulo

  More Information

No publications provided

Responsible Party: Ana Regina Noto, Adjunct Professor at the Psychobiology Department, Federal University of São Paulo

ClinicalTrials.gov Identifier: NCT02127411    History of Changes 

Other Study ID Numbers: MBRP BZD, CNPq and Fapesp

Study First Received: March 10, 2014

Last Updated: September 3, 2014

Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:

Mindfulness

Benzodiazepines

Sleep

Dependence

Relapse Prevention

ClinicalTrials.gov processed this record on June 11, 2015

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As a dude, I don't qualify.

But I look forward towards such.  Mindfulness Meditation does seem to do me good.

No pills.