CompletedNot Applicable

Modification of Goal-directed and Habitual Behavior in Addiction

Germany75 participantsStarted 2020-01-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in imbalance between goal-directed and habitual behavior

Timeframe: 2 time points: before and after 6 weeks SCP

Change in implicit smoking-related associations

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in attentional bias to smoking cues

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in smoking urges

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in working memory capacity

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in planning ability

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in cognitive flexibility

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Trial details

NCT IDNCT03764969

SponsorCentral Institute of Mental Health, Mannheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-23

View on ClinicalTrials.gov More Tobacco Use Disorder trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in imbalance between goal-directed and habitual behavior

Timeframe: 2 time points: before and after 6 weeks SCP

Change in implicit smoking-related associations

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in attentional bias to smoking cues

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in smoking urges

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in working memory capacity

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in planning ability

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months

Change in cognitive flexibility

Timeframe: 3 time points: before and after 6 weeks SCP plus after 3 months