NCT01534624

Brief Summary

Background: \- Researchers are interested in studying the roles that genes play in drug and alcohol addiction. Genes seem to account for about half of the differences between people who become addicted to drugs and people who do not. This study will collect blood and skin cell samples. These cells will be used to develop stem cells that are useful for studying how genes are related to drug use and dependence. Objectives: \- To study genetic and cellular differences between people who are addicted to drugs and those who are not. Eligibility:

  • Individuals between 21 and 65 years of age who do not use drugs.
  • Individuals between 21 and 65 years of age who are in treatment with buprenorphine or methadone. Design:
  • Participants will be screened with a brief physical exam and medical history.
  • Participants will also answer questions about physical and mental health, quality of life, and history of drug and alcohol use. A urine sample and cheek swab sample will be collected.
  • Participants whose genetic samples match the study requirements will be asked to come back to provide a skin biopsy sample and a second urine sample.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

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

February 7, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2014

Completed
Last Updated

December 17, 2019

Status Verified

July 30, 2014

First QC Date

February 15, 2012

Last Update Submit

December 14, 2019

Conditions

Induced Pluripotent Stem Cells

Keywords

Induced Pluripotent Stem Cell (iPS) Cell LinesAddictionAddiction-Associated Human Gene VariantsDopamine Transporter

Outcome Measures

Primary Outcomes (1)

  • Derive and characterize patient-specific, induced pluripotent stem (iPS) cells that carry monoamine transporter polymorphisms and differentiate them into dopaminergic neurons.

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years old
  • Opioid dependent participant group only:
  • enrollment in a substance abuse treatment protocol in Archway.
  • Non-drug users
  • no lifetime history of drug dependence as indicated by the screening ASI and Substance Abuse/Dependence Evaluation counselor interview.

You may not qualify if:

  • Relevant neurological disorders (including, but not limited to, Parkinson s disease and Huntington s disease).
  • contraindications to skin biopsy including, but not limited to, bleeding disorders, skin disorders, and immune disorders, that the MAI determines may alter the risk of the biopsy.
  • cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires.
  • controls will also be excluded if they test positive for drugs or alcohol during screening or study visits.
  • unwillingness to allow samples to be kept for future research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Hyman SE, Malenka RC. Addiction and the brain: the neurobiology of compulsion and its persistence. Nat Rev Neurosci. 2001 Oct;2(10):695-703. doi: 10.1038/35094560.

    PMID: 11584307BACKGROUND

  • Nestler EJ. Molecular basis of long-term plasticity underlying addiction. Nat Rev Neurosci. 2001 Feb;2(2):119-28. doi: 10.1038/35053570.

    PMID: 11252991BACKGROUND

  • Wise RA, Bozarth MA. A psychomotor stimulant theory of addiction. Psychol Rev. 1987 Oct;94(4):469-92. No abstract available.

    PMID: 3317472BACKGROUND

MeSH Terms

Conditions

Ichthyosis prematurity syndromeBehavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Kenzie Preston, Ph.D.

    National Institute on Drug Abuse (NIDA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 16, 2012

Study Start

February 7, 2012

Study Completion

July 30, 2014

Last Updated

December 17, 2019

Record last verified: 2014-07-30

Locations

US(1)