Modification of Goal-directed and Habitual Behavior in Addiction

October 4, 2023 updated by: Central Institute of Mental Health, Mannheim

Modification of the Imbalance Between Goal-directed and Habitual Behavior in Human Addiction

This study aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. Two interventions will be used as add-on trainings to a smoking cessation program.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, the investigators aim to assess the imbalance between goal-directed and habitual behavior, its neural basis and how it can be differentially modified in treatment-seeking smokers, using two training interventions. The first intervention is cognitive remediation treatment (CRT), also known as cognitive enhancement therapy, focusing on improving inhibitory control and executive functions. The second intervention, a computer-based habit-modifying training focusing on implicit drug seeking ("implicit computer-based habit-modifying training", ICHT) uses a conditioning approach through implicit priming and contextual modulation. Indicators of the imbalance will be examined with respect to reward devaluation, cue reactivity and a pavlovian instrumental transfer (PIT) paradigm. The investigators hypothesize that both interventions change the balance between goal-directed and habitual behavior but by different mechanisms. Whereas CRT should directly increase cognitive control, in contrast, ICHT should affect the early processing and the emotional valence of smoking and smoking cues.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68159
        • Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • severe tobacco use disorder (TUD) according to DSM-5
  • sufficient ability to communicate with investigators and answer questions in both written and verbal format
  • ability to provide fully informed consent and to use self-rating scales

Exclusion Criteria:

  • severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
  • history of brain injury
  • severe physical diseases
  • common exclusion criteria for MRI (e.g. metal, claustrophobia)
  • positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
  • psychotropic medication within the last 14 days
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: standard smoking cessation program (SCP)
standard smoking cessation program
Behavioral: standard smoking cessation program (SCP)
Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer 2004), and will be carried out by a qualified therapist.
Experimental: SCP + CRT
SCP plus cognitive remediation treatment (CRT)
Behavioral: standard smoking cessation program (SCP)
Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer 2004), and will be carried out by a qualified therapist.
Behavioral: Cognitive remediation treatment (CRT)
Cognitive remediation treatment (CRT) employing a chess-based battery of tasks two times per week over six weeks as a group treatment in our outpatient clinic (60 min duration per session).
Experimental: SCP + ICHT
SCP plus an implicit computer-based habit-modifying training (ICHT)
Behavioral: standard smoking cessation program (SCP)
Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer 2004), and will be carried out by a qualified therapist.
Behavioral: Implicit computer-based habit-modifying training (ICHT)
Implicit computer-based habit-modifying training (ICHT), applied twice a week for six weeks. In this training, the participants perform a two-part training. First, a subliminal presentation (20 ms) of negative valenced primes before smoking-cues in context and secondly, a subliminal presentation of positive valenced primes before potentially reinforcing events.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in imbalance between goal-directed and habitual behavior
Time Frame: 2 time points: before and after 6 weeks SCP
measured by reward devaluation procedure (Hogarth & Chase 2011)
2 time points: before and after 6 weeks SCP
Change in implicit smoking-related associations
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
smoking-related implicit association task (Wiers et al. 2016).
3 time points: before and after 6 weeks SCP plus after 3 months
Change in attentional bias to smoking cues
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
smoking-related dot-probe task (Vollstädt-Klein et al. 2009).
3 time points: before and after 6 weeks SCP plus after 3 months
Change in smoking urges
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
questionnaire of smoking urges (QSU, Müller et al. 2001)); self-report questionnaire; two subscales: "intention and desire to smoke / anticipation of pleasure from smoking" (range 11 - 77) and "anticipation of relief from negative affect and nicotine withdrawal / urgent and overwhelming desire to smoke" (range 10 - 70) high values represent high craving
3 time points: before and after 6 weeks SCP plus after 3 months
Change in working memory capacity
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
Spatial Working Memory task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
3 time points: before and after 6 weeks SCP plus after 3 months
Change in planning ability
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
One Touch Stockings of Cambridge task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
3 time points: before and after 6 weeks SCP plus after 3 months
Change in cognitive flexibility
Time Frame: 3 time points: before and after 6 weeks SCP plus after 3 months
Internal-External Set Shifting task from the Cambridge Automated Neuropsychological Test Automated Battery (Robbins et al. 1994)
3 time points: before and after 6 weeks SCP plus after 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
nicotine consumption
Time Frame: 3 months follow-up
self-report
3 months follow-up
Change in neural PIT effect
Time Frame: 2 time points: before and after 6 weeks SCP
PIT phase of a choice task (adapted from Hogarth & Chase 2011)
2 time points: before and after 6 weeks SCP
Change in neural cue reactivity
Time Frame: 2 time points: before and after 6 weeks SCP
fMRI cue-reactivity task (Vollstädt-Klein et al. 2011)
2 time points: before and after 6 weeks SCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central Institute of Mental Health, Mannheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Herta Flor, Prof. Dr., Central Institute of Mental Health, Mannheim
  • Principal Investigator: Sabine Vollstädt-Klein, Prof. Dr., Central Institute of Mental Health, Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRR265 C01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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