NCT02776319

Brief Summary

The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

4 months

First QC Date

May 16, 2016

Last Update Submit

May 17, 2016

Conditions

Keywords

Non-invasive brain stimulationtobacco use disordercraving

Outcome Measures

Primary Outcomes (1)

  • Tobacco craving

    Subjective craving scale

    During experimentation

Secondary Outcomes (1)

  • Brain metabolites

    During experimentation

Study Arms (2)

Active

EXPERIMENTAL

Non-invasive brain stimulation (active)

Device: Non-invasive brain stimulation (active)

Sham/Placebo

PLACEBO COMPARATOR

Non-invasive brain stimulation (sham)

Device: Non-invasive brain stimulation (sham)

Interventions

Non-invasive brain stimulation (active)

Active

Non-invasive brain stimulation (sham)

Sham/Placebo

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Tobacco use disorder (DSM-V)

You may not qualify if:

  • Other psychiatric disorders
  • Contraindication to non-invasive brain stimulation and MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Social

Québec, Quebec, G1M2S8, Canada

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Antoine Hone-Blanchet, MSC

CONTACT

Shirley Fecteau, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 18, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations