Improvement of Cocaine Use Disorder Treatment Through Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)

NCT ID: NCT05207228

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2024-06-01

Brief Summary

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Addictions are among the most serious and expensive public health problems in Europe and Spain and they present high morbimortality. There is an increasing amount of studies emphasizing the role e-health for improving current treatments in mental health but research in addictions is still scarce. Over the last years, there have been several indicators that show an upward trend in the consumption of cocaine and the highly treatment-resistant patients.

Objectives: 1) To evaluate whether adding a web-based cognitive behavioral therapy (CBT4CBT) to standard cocaine use disorder treatment improves treatment outcomes in a Spanish sample of patients with severe addiction 2) To explore differences between men and women in treatment response and psychopathological risk factors of treatment response. Design: Randomized clinical trial. Selection criteria: patients consecutively admitted to the inpatient treatment unit for cocaine detoxification and meet inclusion criteria. Sample: the total sample will be of 70 individuals (randomly assigned to TAU + web-based CBT4CBT (n=35) or to TAU (n=35)). Assessment: Patients will be assessed at the beginning and during inpatient treatment, before and during outpatient treatment (CBT4CBT or TAU), after outpatient treatment (CBT4CBT or TAU) and at follow ups. Treatment retention, changes on craving and related psychological variables as well as presence of benzoylecgonine in urine will be evaluated.

Detailed Description

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Conditions

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Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment as usual

After completing the inpatient care (at discharge of inpatient care), patients randomized to TAU will receive day-care / outpatient treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment as usual + CBT4CBT

After completing the inpatient care (at discharge), the patients randomly assigned to the experimental condition will receive the TAU + CBT4CBT a web-based treatment which has been tested on individuals with cocaine use disorder in America by the team of Dr. K.M. Carroll.

Group Type EXPERIMENTAL

CBT4CBT

Intervention Type BEHAVIORAL

Cognitive behavioral treatment through the web CBT4CBT

Interventions

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CBT4CBT

Cognitive behavioral treatment through the web CBT4CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* inpatients for cocaine detoxification in our addiction unit who live in Barcelona or surroundings
* abstinent at the time of the study assessment (from the third day of hospitalization)
* 18 years of age or older.

Exclusion Criteria

* indication of treatment for reasons other than cocaine detoxification,
* presence of serious psychopathological or neuropsychological alterations that hinder the participation in the study (including severe intoxication)
* opioid abuse or dependence during the last year (this criteria includes maintenance treatment with methadone or another opioid substance)
* a lack of Spanish or Catalan knowledge or difficulties to read or write that hamper the participation in the study,
* Non-acceptance of the study procedures, such as the signing of informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Núria Mallorquí, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Nuria Mallorquí, PhD

Role: CONTACT

935537665

Anna Alonso, PhD

Role: CONTACT

935537665

Facility Contacts

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Núria Mallorquí, PhD

Role: primary

935537665

References

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Palazon-Llecha A, Trujols J, Madre M, Duran-Sindreu S, Batlle F, Mallorqui-Bague N. The Predictive Value of Emotion Regulation in Cocaine Use Disorder Severity: Psychotherapeutic Implications During Hospitalization for Detoxification. Clin Psychol Psychother. 2025 Sep-Oct;32(5):e70155. doi: 10.1002/cpp.70155.

Reference Type DERIVED
PMID: 40983318 (View on PubMed)

Mallorqui-Bague N, Palazon-Llecha A, Madre M, Batlle F, Duran-Sindreu S, Trujols J. CBT4CBT web-based add-on treatment for cocaine use disorder: Study protocol for a randomized controlled trial. Front Psychiatry. 2023 Mar 2;14:1051528. doi: 10.3389/fpsyt.2023.1051528. eCollection 2023.

Reference Type DERIVED
PMID: 36937712 (View on PubMed)

Other Identifiers

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IIBSP-CTB-2020-116

Identifier Type: -

Identifier Source: org_study_id

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