Increasing Smoking Cessation Success Through Sleep-amplified Memory Consolidation

NCT05726045 | Recruiting

• 1 other identifier: TRR265 C01-P2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this subproject is to examine the hypothesized improvement of treatment with chess-based training and sleep enhancement, both together and on their own, in smokers. Participants will undergo fMRI measurements, sleep monitoring. They will then be assigned to one of the four experimental groups, including high-intensity interval training with or without chess-based training.

Conditions

Tobacco Use Disorder

Keywords

Addiction; Nicotine; Smoking Cessation; Relapse; Cognitive remediation; Exercise training

Outcome Measures

Primary Outcomes (6)

• Time until first severe relapse

  days until the first severe smoking relapse after treatment

  timepoint 3: follow-up 3 months after end of SCP

• Percentage of abstinent days

  Percentage of abstinent days in the 3 months after treatment

  timepoint 3: follow-up 3 months after end of SCP

• Change in smoking urges

  questionnaire of smoking urges (QSU, Müller et al. 2001)

  2 time points: before and after 6 weeks SCP

• Change in neural measures of response inhibition

  SST fMRI task (Gan et al., 2014)

  2 time points: before and after 6 weeks SCP

• Change in neural measures of working memory

  Nback fMRI task (Charlet et al., 2014)

  2 time points: before and after 6 weeks SCP

• Change in neural functional connectivity in the salience network

  resting state connectivity to seed region right anterior insula

  2 time points: before and after 6 weeks SCP

Study Arms (4)

HIIT morning

ACTIVE COMPARATOR

High-intensity interval training (HIIT) in the morning

Behavioral: Standard smoking cessation program (SCP)

HIIT evening

EXPERIMENTAL

High-intensity interval training (HIIT) in the evening

Behavioral: Standard smoking cessation program (SCP); Behavioral: High-intensity interval training (HIIT evening)

HIIT morning + CRT

ACTIVE COMPARATOR

High-intensity interval training (HIIT) in the morning + cognitive remediation treatment (CRT)

Behavioral: Standard smoking cessation program (SCP); Behavioral: Cognitive remediation treatment (CRT)

HIIT evening + CRT

EXPERIMENTAL

High-intensity interval training (HIIT) in the evening+ cognitive remediation treatment (CRT)

Behavioral: Standard smoking cessation program (SCP); Behavioral: Cognitive remediation treatment (CRT); Behavioral: High-intensity interval training (HIIT evening)

Interventions

Standard smoking cessation program (SCP) BEHAVIORAL

Each subject will receive a standard SCP as group treatment once a week (1h) 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.

HIIT evening; HIIT evening + CRT; HIIT morning; HIIT morning + CRT

Cognitive remediation treatment (CRT) BEHAVIORAL

The cognitive remediation treatment (CRT) employs a chess-based battery of tasks (delivered through an app-based online tool), two times per week over six weeks (60min duration per session).

HIIT evening + CRT; HIIT morning + CRT

High-intensity interval training (HIIT evening) BEHAVIORAL

The high-intensity interval training will be delivered through an app environment with several choices of exercise, two times per week over six weeks. The training will include a 5-minutes warm-up and cool down phase. In between, participants will perform four 4-minutes blocks of exercise at high intensity, interspersed with three 3-minute blocks of low intensity (total of 35 minutes exercise).

HIIT evening; HIIT evening + CRT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• right-handedness
• HIIT can be performed without the risk of side effect (medical sports check)

You may not qualify if:

• 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
• positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
• psychotropic medication within the last 14 days
• pregnancy

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

RECRUITING

Related Publications (1)

• Gerhardt S, Kroth M, Seeger A, Schmitt R, Fritz H, Diring L, Shevchenko Y, Ersche KD, Feld G, Vollstadt-Klein S. Increasing the smoking cessation success rate by enhancing improvement of self-control through sleep-amplified memory consolidation: protocol of a randomized controlled, functional magnetic resonance study. BMC Psychol. 2025 Feb 22;13(1):157. doi: 10.1186/s40359-025-02482-w.

  PMID: 39987116 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Behavior, Addictive; Smoking Cessation; Recurrence

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Health Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sabine Vollstädt-Klein, Prof. Dr.

  Central Institute of Mental Health, Mannheim

  PRINCIPAL INVESTIGATOR

• Gordon Feld, Dr.

  Central Institute of Mental Health, Mannheim

  PRINCIPAL INVESTIGATOR

• Karen Ersche, Prof. Dr.

  Central Institute of Mental Health, Mannheim

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Vollstädt-Klein, Prof. Dr.

CONTACT

+49-621/1703; s.vollstaedt-klein@zi-mannheim.de

Gordon Feld, Dr.

CONTACT

+49-621/1703; gordon.feld@zi-mannheim.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

DE (1)