NCT03502486

Brief Summary

The study is a crossover randomised controlled trial. Alcohol or cocaine dependent participants will be recruited from inpatient and outpatient psychiatric treatment centres, on the approval of their treating physician. A healthy control group will be recruited using online advertising. All participants will undergo each of three conditions in a randomised order; 1) 20 minutes of cycle ergometry at 50-60% of maximum heart rate; 2) 20 minutes of exercise at 70-80% of maximum heart rate; 3) 20 minutes of quiet reading. Immediately before and after each condition, participants will be asked to complete a computerised Stroop test, watch a film containing substance-related images, and self-report craving levels. During the Stroop test and film viewing, participants' neural activity will be measured via functional near-infrared spectroscopy

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 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

July 5, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

2.1 years

First QC Date

April 5, 2018

Last Update Submit

April 19, 2018

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (4)

  • Stroop test accuracy

    Accuracy on Stroop test

    Change from Baseline after 20 minute acute condition

  • Self-reported craving

    Sum score on Alcohol Craving Questionnaire Short Form (scale range 12 to 84, higher scores representing greater craving) or Cocaine Craving Questionnaire - Brief (scale range 10 to 70, higher scores representing greater craving)

    Change from Baseline after 20 minute acute condition

  • Cerebral oxygenation in prefrontal cortex

    Functional near infrared spectroscopic imaging of hemodynamic activity in prefrontal cortex

    Change from Baseline after 20 minute acute condition

  • Stroop test reaction time

    Reaction time on Stroop test

    Change from Baseline after 20 minute acute condition

Study Arms (3)

Moderate exercise

EXPERIMENTAL

20 minutes of cycle ergometry at 50 - 60% of heart rate max.

Other: Moderate exercise

Intense Exercise

EXPERIMENTAL

20 minutes of cycle ergometry at 70 - 80% of heart rate max.

Other: Intense exercise

Rest

ACTIVE COMPARATOR

20 minutes of seated reading.

Other: Reading

Interventions

Moderate exerciseOTHER

20 minutes of cycle ergometry at 50-60% of heart rate max

Moderate exercise
Intense exerciseOTHER

20 minutes of cycle ergometry at 70-80% of heart rate max

Intense Exercise
ReadingOTHER

20 minutes of seated reading

Rest

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For alcohol or cocaine dependent participants:
  • meeting three or more of the DSM-IV criteria for substance dependence (as determined by treating physician);
  • minimum of 20 days and maximum of 40 days abstinence from substance of dependence;
  • able to understand and complete the informed consent;
  • able to travel to study site independently, as confirmed by the treating psychiatrist;
  • assessed for physical and mental fitness by treating physician and cleared to take part in the study;
  • fewer than 3 hours of physical exercise or sport per week;
  • For healthy controls:
  • fewer than 3 hours of physical exercise or sport per week;
  • no history of problematic alcohol or illicit drug consumption.

You may not qualify if:

  • Pregnancy
  • Questionable findings during resting ECG screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport, Exercise and Health, University of Basel

Basel, 4052, Switzerland

RECRUITING

Related Publications (1)

  • Colledge F, Ludyga S, Mucke M, Puhse U, Gerber M. The effects of an acute bout of exercise on neural activity in alcohol and cocaine craving: study protocol for a randomised controlled trial. Trials. 2018 Dec 29;19(1):713. doi: 10.1186/s13063-018-3062-0.

    PMID: 30594237DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Flora Colledge, PhD

    University of Basel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Flora Colledge, PhD

CONTACT

0041622074787flora.colledge@unibas.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral researcher

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 18, 2018

Study Start

July 5, 2017

Primary Completion

August 1, 2019

Study Completion

November 1, 2020

Last Updated

April 20, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)