NCT00687089

Brief Summary

People who addicted to Heroin and other opiates suffer from a disease with approved genetic basis. It causes to a behavioral response as searching and using those drugs even though they know it causes severe damages as physiological, familiar and legal affairs. The popular treatment's goal is to "clean" the people from any drug. In a medical and pharmacological point of view there is no sense in this approach for all people. This point of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment. The hypothesis of this research is that people using Buprenorphine have difficulties in gaining weight, in sexual and cognitive function (according to subjects' reports)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 27, 2009

Status Verified

January 1, 2009

Enrollment Period

7 months

First QC Date

May 27, 2008

Last Update Submit

January 25, 2009

Conditions

Keywords

OpiatesSubutexBuprenorphinePatients who addicted to opiates

Outcome Measures

Primary Outcomes (1)

  • ASI quationarry, neurocognitive computerized tests, MMSE test, Sexual function questionnaire and satisfaction questionnaire

    In 2 visits during the study

Study Arms (1)

Subutex group

People who used opiates and willing to start with subutex treatment

Other: Sexual, cognitive functional tests and measurement weight

Interventions

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

People who suffer from addiction problems (opiates) and willing to start Buprenorphine treatment

You may qualify if:

  • People who suffer from addiction problems (opiates)
  • People who willing to to start Buprenorphine treatment
  • People who willing to cooperate with study tests and questionnaires
  • People aged 18 to 70

You may not qualify if:

  • People who suffer from any neurocognitive problems
  • People who suffer from mental illnesses
  • People who are having legal guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Sex

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 27, 2008

First Posted

May 30, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 27, 2009

Record last verified: 2009-01