NCT02810574

Brief Summary

The purpose of this study is to determine whether combining noninvasive brain stimulation with cognitive training can reduce craving in adults with tobacco use disorder.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

May 31, 2016

Last Update Submit

June 20, 2016

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes in tobacco craving assessed by the Questionnaire of Smoking Urge

    immediately before and immediately after the end of the noninvasive brain stimulation

Study Arms (2)

Active noninvasive brain stimulation and cognitive training

ACTIVE COMPARATOR

In active condition, subject will receive stimulation during all the 30-minute stimulation period combined with cognitive training.

Behavioral: Cognitive trainingDevice: Noninvasive brain stimulation (active)

Sham noninvasive brain stimulation

SHAM COMPARATOR

In sham condition, subject will receive stimulation only during the first 30 seconds of the 30-minute stimulation period combined with cognitive training.

Behavioral: Cognitive trainingDevice: Noninvasive brain stimulation (sham)

Interventions

Cognitive trainingBEHAVIORAL
Active noninvasive brain stimulation and cognitive trainingSham noninvasive brain stimulation
Noninvasive brain stimulation (active)DEVICE

Neuroconn DC-STIMULATOR PLUS

Active noninvasive brain stimulation and cognitive training
Noninvasive brain stimulation (sham)DEVICE

Neuroconn DC-STIMULATOR PLUS

Sham noninvasive brain stimulation

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Smoking \> 15 cigarettes per day
  • Tobacco Use Disorder according to Diagnostic and Statistical Manual V criteria

You may not qualify if:

  • Contraindications to noninvasive brain stimulation
  • Psychiatric or neurologic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Interdisciplinaire de Recherche en Réadaptation et Intégration

Québec, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Marine Mondino, PhD

CONTACT

418-529-9141

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 23, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

September 1, 2017

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

CA(1)