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

NCT05207228 | Unknown DMC

• 1 other identifier: IIBSP-CTB-2020-116
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Use Disorder

Keywords

Cocaine Use Disorder; Treatment

Outcome Measures

Primary Outcomes (10)

• Relapse

  Change from baseline at 14 days of inpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine after hospitalization and before starting Arm 1 or 2.

  Through hospitalization completion, an average of 14 days

• Relapse

  Change from baseline at 8 weeks of outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine during the 8-week period of Arm 1 or 2.

  Through the 8-week period of arm 1 or 2.

• Relapse

  Change from baseline at 1 month after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up time point.

  At 1 month follow-up after Arm 1 or 2

• Relapse

  Change from baseline at 3 months after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up time point.

  At 3 months follow-up after Arm 1 or 2

• Relapse

  5\. Change from baseline at 6 months after outpatient treatment, assessing presence of benzoylecgonine (metabolite of cocaine) in urine at follow-up timepoint.

  At 6 months follow-up after Arm 1 or 2

• Treatment retention

  Change from baseline at 14 days of inpatient treatment, after hospitalization and before starting Arm 1 or 2.

  Through hospitalization completion, an average of 14 days

• Treatment retention

  Change from baseline at 8 weeks of outpatient treatment during the 8-week period of Arm 1 or 2.

  Through the 8-week period of arm 1 or 2

• Treatment retention

  Change from baseline at 1 month after outpatient treatment.

  At 1 month follow-up after completing Arm 1 or 2

• Treatment retention

  Change from baseline at 3 months after outpatient treatment.

  At 3 months follow-up after completing Arm 1 or 2

• Treatment retention

  Change from baseline treatment retention versus drop out at 6 months after treatment at follow-up time point.

  At 6 months follow-up after completing Arm 1 or 2

Secondary Outcomes (11)

• Psychopathology, dependence and craving, as well as anthropometric measures

  At baseline, at the beginning of hospitalization

• Psychopathology, dependence and craving, as well as anthropometric measures

  At hospitalization completion, an average of 14 days

• Psychopathology, dependence and craving, as well as anthropometric measures

  Once the 8-week outpatient treatment is completed

• Psychopathology, dependence and craving, as well as anthropometric measures

  At 1 month follow-up after Arm 1 or 2 completion

• Psychopathology, dependence and craving, as well as anthropometric measures

  At 3 months follow-up after Arm 1 or 2 completion

Study Arms (2)

Treatment as usual

NO INTERVENTION

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

Treatment as usual + CBT4CBT

EXPERIMENTAL

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.

Behavioral: CBT4CBT

Interventions

CBT4CBT BEHAVIORAL

Cognitive behavioral treatment through the web CBT4CBT

Treatment as usual + CBT4CBT

Eligibility Criteria

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

You may qualify if:

• 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)
• years of age or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 40983318 DERIVED

• 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.

  PMID: 36937712 DERIVED

Study Officials

• Núria Mallorquí, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuria Mallorquí, PhD

CONTACT

935537665; nmallorqui@santpau.cat

Anna Alonso, PhD

CONTACT

935537665; aalonsos@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: January 26, 2022
• Study Start: April 12, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

ES (1)