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

Randomized Clinical Trial (RCT) for the Improvement of Cocaine Use Disorder Treatment Through the Implementation of a Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)

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.

Study Overview

• Status: Recruiting
• Conditions: Cocaine Use Disorder
• Intervention / Treatment: Behavioral: CBT4CBT

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Núria Mallorquí, PhD; Phone Number: 935537665; Email: nmallorqui@santpau.cat
• Study Contact Backup: Name: Anna Alonso, PhD; Phone Number: 935537665; Email: aalonsos@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital Santa Creu i Sant Pau
    • Contact: Núria Mallorquí, PhD; Phone Number: 935537665; Email: nmallorqui@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual; After completing the inpatient care (at discharge of inpatient care), patients randomized to TAU will receive day-care / outpatient treatment.
Experimental: 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.	Behavioral: CBT4CBT; Cognitive behavioral treatment through the web CBT4CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychopathology, dependence and craving, as well as anthropometric measures	MINI international neuropsychiatric interview; Symptom CheckList-90 items-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom.; The State-Trait Anxiety Inventory. Every sub-scale has a total score, ranging from 20 to 80, with higher scores correlating with greater anxiety.; Beck's Depression Inventory. The total score ranges from 0 to 63, with higher scores indicating a greater severity of the symptoms.; Severity of Dependence Scale. The total score ranges from 0 to 15, with a higher score indicating grater dependence.; Cocaine Selective Severity Assessment. The scale has a total score ranging from 0 to 126, where a higher score indicates more severity of the withdrawal symptoms.; Weiss Cocaine Craving Scale. The total score ranges from 0 to 45, where a higher score indicates more severity of craving symptomatology.; Weight is measured in kilograms (Kg); Heigh is measured in meters (m)	At baseline, at the beginning of hospitalization
Psychopathology, dependence and craving, as well as anthropometric measures	Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom.; The State-Trait Anxiety Inventory. Every sub-scale has a total score, ranging from 20 to 80, with higher scores correlating with greater anxiety.; Beck's Depression Inventory. This instrument has a total score ranging from 0 to 63, with higher scores indicating a greater severity of the symptoms.; Severity of Dependence Scale. This questionnaire provides a total score ranging from 0 to 15, with a higher score indicating grater dependence.; Cocaine Selective Severity Assessment. The scale has a total score ranging from 0 to 126, where a higher score indicates more severity of the withdrawal symptoms.; Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology.; Weight is measured in kilograms (Kg); Heigh is measured in meters (m)	At hospitalization completion, an average of 14 days
Psychopathology, dependence and craving, as well as anthropometric measures	Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom.; The State-Trait Anxiety Inventory. Every sub-scale has a total score, ranging from 20 to 80, with higher scores correlating with greater anxiety.; Beck's Depression Inventory. This instrument has a total score ranging from 0 to 63, with higher scores indicating a greater severity of the symptoms.; Severity of Dependence Scale. This questionnaire provides a total score ranging from 0 to 15, with a higher score indicating grater dependence.; Cocaine Selective Severity Assessment. The scale has a total score ranging from 0 to 126, where a higher score indicates more severity of the withdrawal symptoms.; Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology.; Weight is measured in kilograms (Kg); Heigh is measured in meters (m)	Once the 8-week outpatient treatment is completed
Psychopathology, dependence and craving, as well as anthropometric measures	Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom.; Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology.; Weight is measured in kilograms (Kg); Heigh is measured in meters (m)	At 1 month follow-up after Arm 1 or 2 completion
Psychopathology, dependence and craving, as well as anthropometric measures	Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom.; Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology.; Weight is measured in kilograms (Kg); Heigh is measured in meters (m)	At 3 months follow-up after Arm 1 or 2 completion
Psychopathology, dependence and craving, as well as anthropometric measures	Symptom CheckList-90 item-Revised. Each dimension has a total score ranging from 0 to 4, where a higher score means higher severity of the symptom.; Weiss Cocaine Craving Scale. The questionnaire has a total score ranging from 0 to 45 where a higher score indicates more severity of craving symptomatology.; Weight is measured in kilograms (Kg); Heigh is measured in meters (m)	At 6 months follow-up after Arm 1 or 2 completion
Addictive behaviors	South Oaks Gambling Screen. The questionnaire consists of 20 items that lead to a total score, ranging from 0 to 20. As higher is the total score, higher is the probability of pathological gambling.; Yale Food Addiction Scale 2. Each item is answered using a 7-point likert scale, ranging from 0 (never) to 7 (always). If the criterion is met, then it is scored as 1. If the score is 0 it means that the criterion has not been met. As more criteria are met, greater is the severity of food addiction.; Internet Gambling Disorder (IGM) DSM-5 criteria. As more items are answered as yes, higher is the severity of the internet addiction.; Hypersexual Behavior Inventory. Each item is answered using a 5-point likert scale, ranging from 1 (never) to 5 (very often). There are 3 factors and each factor has a total score, so as higher is the score in each factor, higher is the hypersexual behaviour.	At baseline, at the beginning of hospitalization
Addictive behaviors	South Oaks Gambling Screen. The questionnaire consists of 20 items that lead to a total score, ranging from 0 to 20. As higher is the total score, higher is the probability of pathological gambling.; Yale Food Addiction Scale 2. Each item is answered using a 7-point likert scale, ranging from 0 (never) to 7 (always). If the criterion is met, then it is scored as 1. If the score is 0 it means that the criterion has not been met. As more criteria are met, greater is the severity of food addiction.; Internet Gambling Disorder (IGM) DSM-5 criteria. As more items are answered as yes, higher is the severity of the internet addiction.; Hypersexual Behavior Inventory. Each item is answered using a 5-point likert scale, ranging from 1 (never) to 5 (very often). There are 3 factors and each factor has a total score, so as higher is the score in each factor, higher is the hypersexual behaviour.	Once the 8-week outpatient treatment is completed
Personality and emotion regulation	Sensitivity to Punishment and Sensitivity to Reward Questionnaire. The score of each scale ranges from 0 to 24, with a greater score indicating more sensitivity to punishment or to reward.; UPPS-P Impulsive Behaviour Scale. Items are answered using a 4-point likert scale. Each sub-scale has a total score, where high values indicate higher levels of impulsivity.; Difficulties in Emotion Regulation Scale. Each item is answered using a 5-point likert scale, and each sub-scale has a total score. As higher is the score in the sub-scale, there are more difficulties in emotional regulation.; Emotion Regulation Questionnaire. Items are answered using a 7-point likert scale. Each sub-scale has a total score, where a higher value indicates a greater use of that emotion regulation strategy.; Multidimensional Assessment of Interoceptive Awareness. Each item is answered using a 5-point likert scale. There are 8 sub-scales where higher scores indicate higher levels of positive awareness.	At baseline, at the beginning of hospitalization
Personality and emotion regulation	UPPS-P Impulsive Behaviour Scale. Items are answered using a 4-point likert scale. Each sub-scale has a total score, where high values indicate higher levels of impulsivity.; Difficulties in Emotion Regulation Scale. Each item is answered using a 5-point likert scale, and each sub-scale has a total score. As higher is the score in the sub-scale, there are more difficulties in emotional regulation.; Emotion Regulation Questionnaire. Items are answered using a 7-point likert scale. Each sub-scale has a total score, where a higher value indicates a greater use of that emotion regulation strategy.	At hospitalization completion, an average of 14 days
Personality and emotion regulation	UPPS-P Impulsive Behaviour Scale. Items are answered using a 4-point likert scale. Each sub-scale has a total score, where high values indicate higher levels of impulsivity.; Difficulties in Emotion Regulation Scale. Each item is answered using a 5-point likert scale, and each sub-scale has a total score. As higher is the score in the sub-scale, there are more difficulties in emotional regulation.; Emotion Regulation Questionnaire. Items are answered using a 7-point likert scale. Each sub-scale has a total score, where a higher value indicates a greater use of that emotion regulation strategy.	Once the 8-week outpatient treatment is completed

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Núria Mallorquí, PhD, Hospital Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Treatment; Cocaine Use Disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: IIBSP-CTB-2020-116

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No