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Cocaine Use DisorderNCT05207228

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

A study testing CBT4CBT in people with Cocaine Use Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cocaine Use Disorder
What is being tested?
CBT4CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSpain
Study dates
12 Apr 2021to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Nuria Mallorquí, PhD contact

935537665

nmallorqui@santpau.cat

Anna Alonso, PhD contact

935537665

aalonsos@santpau.cat

Spain1 site, 1 recruiting

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08041

    Núria Mallorquí, PhD, 935537665, nmallorqui@santpau.cat

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Being tested
CBT4CBT
Keywords
Cocaine Use Disorder, Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT4CBTBehavioural

    Cognitive behavioral treatment through the web CBT4CBT

Study groups in NCT05207228
Study groupRoleWhat they receive
Treatment as usualNo interventionAfter completing the inpatient care (at discharge of inpatient care), patients randomized to TAU will receive day-care / outpatient treatment.
Treatment as usual + CBT4CBTExperimentalAfter 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.
Receives: Behavioral: CBT4CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through hospitalization completion, an average of 14 days

  2. 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.

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

  3. Relapse

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

    Measured: At 1 month follow-up after Arm 1 or 2

  4. Relapse

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

    Measured: At 3 months follow-up after Arm 1 or 2

  5. Relapse

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

    Measured: At 6 months follow-up after Arm 1 or 2

  6. Treatment retention

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

    Measured: Through hospitalization completion, an average of 14 days

  7. Treatment retention

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

    Measured: Through the 8-week period of arm 1 or 2

  8. Treatment retention

    Change from baseline at 1 month after outpatient treatment.

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

  9. Treatment retention

    Change from baseline at 3 months after outpatient treatment.

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

  10. Treatment retention

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

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

Secondary outcomes (11)

  1. 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)

    Measured: At baseline, at the beginning of hospitalization

  2. 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)

    Measured: At hospitalization completion, an average of 14 days

  3. 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)

    Measured: Once the 8-week outpatient treatment is completed

  4. 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)

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

  5. 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)

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

  6. 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)

    Measured: At 6 months follow-up after Arm 1 or 2 completion

  7. 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.

    Measured: At baseline, at the beginning of hospitalization

  8. 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.

    Measured: Once the 8-week outpatient treatment is completed

  9. 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.

    Measured: At baseline, at the beginning of hospitalization

  10. 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.

    Measured: At hospitalization completion, an average of 14 days

  11. 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.

    Measured: Once the 8-week outpatient treatment is completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start12 Apr 2021
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207228
Sponsor's protocol ID
IIBSP-CTB-2020-116
Status last verified
May 2022
First submitted
8 Apr 2021
Last updated
2 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40983318

  • 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.

    PubMed 36937712

Questions about this trial

What is this clinical trial studying?

A study testing CBT4CBT in people with Cocaine Use Disorder, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nuria Mallorquí, PhD (935537665, nmallorqui@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse (time frame: Through hospitalization completion, an average of 14 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207228, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.

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