Substance AbuseNCT00247819
The Genetic Basis for Vulnerability to Substance Abuse
An observational study of Substance Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
This investigation seeks to better define the genetic basis for vulnerability to substance abuse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 8,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1992to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Substance abusers
- Allow for blood draw
Who cannot join
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Official title: Allelic Linkage in Substance Abuse
This investigation seeks to better define the genetic basis for vulnerability to substance abuse.
Read the detailed description
Dopamine (DA), a neurotransmitter helping to mediate reward and reinforcement, has been putatively linked to the development of substance abuse, alcohol abuse, and alcoholism. Identification of specific vulnerability-association alleles for receptors, other molecules within the reward mediating system, and other genes that may predispose individuals to the development of such disorders is the goal of the study.
This investigation will help elucidate the genetic underpinnings of substance abuse, potentially leading to the improved methods to diagnose those at risk and to help develop better therapeutic interventions.
- Conditions
- Substance Abuse
- Being tested
- Blood draw
- Keywords
- Substance abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startAug 1992
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- George Uhl, M.D., Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247819
- Sponsor's protocol ID
- NIDA-IRP-148
- Status last verified
- Oct 2005
- First submitted
- 31 Oct 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Publications
Noble EP, Blum K, Khalsa ME, Ritchie T, Montgomery A, Wood RC, Fitch RJ, Ozkaragoz T, Sheridan PJ, Anglin MD, et al. Allelic association of the D2 dopamine receptor gene with cocaine dependence. Drug Alcohol Depend. 1993 Oct;33(3):271-85. doi: 10.1016/0376-8716(93)90113-5.
PubMed 8261891Clark CJ, Downie CC. A method for the rapid determination of the number of patients to include in a controlled clinical trial. Lancet. 1966 Dec 17;2(7477):1357-8. doi: 10.1016/s0140-6736(66)92098-8. No abstract available.
PubMed 4162809Grandy DK, Litt M, Allen L, Bunzow JR, Marchionni M, Makam H, Reed L, Magenis RE, Civelli O. The human dopamine D2 receptor gene is located on chromosome 11 at q22-q23 and identifies a TaqI RFLP. Am J Hum Genet. 1989 Nov;45(5):778-85.
PubMed 2573278Hill SY, Armstrong J, Steinhauer SR, Baughman T, Zubin J. Static ataxia as a psychobiological marker for alcoholism. Alcohol Clin Exp Res. 1987 Aug;11(4):345-8. doi: 10.1111/j.1530-0277.1987.tb01323.x.
PubMed 3307504Shigeta Y, Ishii H, Takagi S, Yoshitake Y, Hirano T, Takata H, Kohno H, Tsuchiya M. HLA antigens as immunogenetic markers of alcoholism and alcoholic liver disease. Pharmacol Biochem Behav. 1980;13 Suppl 1:89-94. doi: 10.1016/s0091-3057(80)80014-1.
PubMed 7243836Smith SS, O'Hara BF, Persico AM, Gorelick DA, Newlin DB, Vlahov D, Solomon L, Pickens R, Uhl GR. Genetic vulnerability to drug abuse. The D2 dopamine receptor Taq I B1 restriction fragment length polymorphism appears more frequently in polysubstance abusers. Arch Gen Psychiatry. 1992 Sep;49(9):723-7. doi: 10.1001/archpsyc.1992.01820090051009.
PubMed 1355337Uhl GR, Liu QR, Walther D, Hess J, Naiman D. Polysubstance abuse-vulnerability genes: genome scans for association, using 1,004 subjects and 1,494 single-nucleotide polymorphisms. Am J Hum Genet. 2001 Dec;69(6):1290-300. doi: 10.1086/324467. Epub 2001 Nov 6.
PubMed 11704927Moolchan ET, Radzius A, Epstein DH, Uhl G, Gorelick DA, Cadet JL, Henningfield JE. The Fagerstrom Test for Nicotine Dependence and the Diagnostic Interview Schedule: do they diagnose the same smokers? Addict Behav. 2002 Jan-Feb;27(1):101-13. doi: 10.1016/s0306-4603(00)00171-4.
PubMed 11800217Uhl GR, Liu QR, Naiman D. Substance abuse vulnerability loci: converging genome scanning data. Trends Genet. 2002 Aug;18(8):420-5. doi: 10.1016/s0168-9525(02)02719-1.
PubMed 12142011Stein L, Belluzzi J. Second messengers, natural rewards, and drugs of abuse. Clin Neuropharmacol. 1986;9 Suppl 4:205-7. No abstract available.
PubMed 3032425Uhl GR, Gold LH, Risch N. Genetic analyses of complex behavioral disorders. Proc Natl Acad Sci U S A. 1997 Apr 1;94(7):2785-6. doi: 10.1073/pnas.94.7.2785. No abstract available.
PubMed 9096294Uhl GR, Persico AM, Smith SS. Current excitement with D2 dopamine receptor gene alleles in substance abuse. Arch Gen Psychiatry. 1992 Feb;49(2):157-60. doi: 10.1001/archpsyc.1992.01820020068010. No abstract available.
PubMed 1347991Johnson EO, van den Bree MB, Uhl GR, Pickens RW. Indicators of genetic and environmental influences in drug abusing individuals. Drug Alcohol Depend. 1996 May;41(1):17-23. doi: 10.1016/0376-8716(96)01223-9.
PubMed 8793306Uhl GR. Molecular genetics of substance abuse vulnerability: a current approach. Neuropsychopharmacology. 1999 Jan;20(1):3-9. doi: 10.1016/S0893-133X(98)00061-X. No abstract available.
PubMed 9885780Wise RA. Action of drugs of abuse on brain reward systems. Pharmacol Biochem Behav. 1980;13 Suppl 1:213-23. doi: 10.1016/s0091-3057(80)80033-5. No abstract available.
PubMed 6113601
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allelic Linkage in Substance Abuse
- ClinicalTrials.gov ID
- NCT00247819
- Acronym / sponsor ID
- NIDA-IRP-148
- Conditions
- Substance Abuse
- Keywords
- Substance abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 1992
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 2 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigation seeks to better define the genetic basis for vulnerability to substance abuse.
Detailed description
Dopamine (DA), a neurotransmitter helping to mediate reward and reinforcement, has been putatively linked to the development of substance abuse, alcohol abuse, and alcoholism. Identification of specific vulnerability-association alleles for receptors, other molecules within the reward mediating system, and other genes that may predispose individuals to the development of such disorders is the goal of the study.
This investigation will help elucidate the genetic underpinnings of substance abuse, potentially leading to the improved methods to diagnose those at risk and to help develop better therapeutic interventions.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Substance abusers
- Allow for blood draw
Key exclusion criteria (1 listed)
- Cognitively impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Background: PubMed 8261891Noble EP, Blum K, Khalsa ME, Ritchie T, Montgomery A, Wood RC, Fitch RJ, Ozkaragoz T, Sheridan PJ, Anglin MD, et al. Allelic association of the D2 dopamine receptor gene with cocaine dependence. Drug Alcohol Depend. 1993 Oct;33(3):271-85. doi: 10.1016/0376-8716(93)90113-5.
- Background: PubMed 4162809Clark CJ, Downie CC. A method for the rapid determination of the number of patients to include in a controlled clinical trial. Lancet. 1966 Dec 17;2(7477):1357-8. doi: 10.1016/s0140-6736(66)92098-8. No abstract available.
- Background: PubMed 2573278Grandy DK, Litt M, Allen L, Bunzow JR, Marchionni M, Makam H, Reed L, Magenis RE, Civelli O. The human dopamine D2 receptor gene is located on chromosome 11 at q22-q23 and identifies a TaqI RFLP. Am J Hum Genet. 1989 Nov;45(5):778-85.
- Background: PubMed 3307504Hill SY, Armstrong J, Steinhauer SR, Baughman T, Zubin J. Static ataxia as a psychobiological marker for alcoholism. Alcohol Clin Exp Res. 1987 Aug;11(4):345-8. doi: 10.1111/j.1530-0277.1987.tb01323.x.
- Background: PubMed 7243836Shigeta Y, Ishii H, Takagi S, Yoshitake Y, Hirano T, Takata H, Kohno H, Tsuchiya M. HLA antigens as immunogenetic markers of alcoholism and alcoholic liver disease. Pharmacol Biochem Behav. 1980;13 Suppl 1:89-94. doi: 10.1016/s0091-3057(80)80014-1.
- Background: PubMed 1355337Smith SS, O'Hara BF, Persico AM, Gorelick DA, Newlin DB, Vlahov D, Solomon L, Pickens R, Uhl GR. Genetic vulnerability to drug abuse. The D2 dopamine receptor Taq I B1 restriction fragment length polymorphism appears more frequently in polysubstance abusers. Arch Gen Psychiatry. 1992 Sep;49(9):723-7. doi: 10.1001/archpsyc.1992.01820090051009.
- Background: PubMed 11704927Uhl GR, Liu QR, Walther D, Hess J, Naiman D. Polysubstance abuse-vulnerability genes: genome scans for association, using 1,004 subjects and 1,494 single-nucleotide polymorphisms. Am J Hum Genet. 2001 Dec;69(6):1290-300. doi: 10.1086/324467. Epub 2001 Nov 6.
- Background: PubMed 11800217Moolchan ET, Radzius A, Epstein DH, Uhl G, Gorelick DA, Cadet JL, Henningfield JE. The Fagerstrom Test for Nicotine Dependence and the Diagnostic Interview Schedule: do they diagnose the same smokers? Addict Behav. 2002 Jan-Feb;27(1):101-13. doi: 10.1016/s0306-4603(00)00171-4.
- Background: PubMed 12142011Uhl GR, Liu QR, Naiman D. Substance abuse vulnerability loci: converging genome scanning data. Trends Genet. 2002 Aug;18(8):420-5. doi: 10.1016/s0168-9525(02)02719-1.
- Background: PubMed 3032425Stein L, Belluzzi J. Second messengers, natural rewards, and drugs of abuse. Clin Neuropharmacol. 1986;9 Suppl 4:205-7. No abstract available.
- Background: PubMed 9096294Uhl GR, Gold LH, Risch N. Genetic analyses of complex behavioral disorders. Proc Natl Acad Sci U S A. 1997 Apr 1;94(7):2785-6. doi: 10.1073/pnas.94.7.2785. No abstract available.
- Background: PubMed 1347991Uhl GR, Persico AM, Smith SS. Current excitement with D2 dopamine receptor gene alleles in substance abuse. Arch Gen Psychiatry. 1992 Feb;49(2):157-60. doi: 10.1001/archpsyc.1992.01820020068010. No abstract available.
Related trials for Substance Abuse
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Uhl, M.D., Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Abuse, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00247819, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.