NCT02308878

Brief Summary

Heroin use has been related to brain dysfunction particularly in the prefrontal cortex. These effects are evident in neuropsychological impairments in attention, memory and executive functioning of heroin users. To assess these deficits and the application of a novel approach of cognitive stimulation to heroin users in treatment for opioid dependence, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with opioid dependence were submitted to cognitive stimulation during four weeks in a three-day/week basis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

6.3 years

First QC Date

December 2, 2014

Last Update Submit

May 9, 2023

Conditions

Substance Use Disorder

Keywords

Opioid Abuse DisorderCognitive TherapyExecutive FunctionMobile HealthRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in the results of Frontal Assessment Battery - FAB

    The participants were assessed in frontal lobe functions at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month.

    1 month

Study Arms (2)

Treatment-as-usual

NO INTERVENTION

This group consists of treatment-as-usual for opioid dependence syndrome.

Mobile health cognitive stimulation

EXPERIMENTAL

Cognitive stimulation using mobile technology with m-Health applications.

Behavioral: Mobile health cognitive stimulation

Interventions

Mobile health cognitive stimulationBEHAVIORAL
Mobile health cognitive stimulation

Eligibility Criteria

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

You may qualify if:

  • Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised will be included in the study.

You may not qualify if:

  • Patients with alcohol dependence or with history of previous neurological disorders will be excluded from the study. Patients will be also screened for minimal computer literacy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ares Do Pinhal-Associação De Recuperação De Toxicodependentes

Sintra, Lisbon District, 2725, Portugal

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD (Full Professor)

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 4, 2014

Study Start

October 1, 2013

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

PT(1)