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Completed

NCT Number: NCT03764969

Modification of Goal-directed and Habitual Behavior in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard smoking cessation program (SCP)

Behavioral

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.

Cognitive remediation treatment (CRT)

Behavioral

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).

Implicit computer-based habit-modifying training (ICHT)

Behavioral

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.

Primary outcomes

  1. 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. 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. 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).

  4. 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

  5. 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)

  6. 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)

  7. 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)

Secondary outcomes

  1. nicotine consumption

    Time frame: 3 months follow-up

    self-report

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2018
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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