Nicotine WithdrawalDDATNCT01492322
SPECT Imaging of DAT Genotype
An observational study of Nicotine Withdrawal, run by University of Pennsylvania at 1 site in United States.
Trial summary
A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is available at the synapse and this may affect the underlying reasons for relapse in smokers. This research will use Single-photon emission computed tomography SPECT and the DAT-specific ligand, TRODAT (Dopamine Transporter Density by… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nicotine Withdrawal
- What is being tested?
- TRODAT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects will be forty physically-healthy and mentally-stable male and non-pregnant female subjects between the ages of 18 and 60 who meet the DSM-IV criteria for nicotine dependence. Subjects will not be excluded based on gender, religion, race, or socioeconomic status. The subject population of previous smoking studies in our lab was 54% female, 62% Caucasian, and averaged 15 years of education. This is representative of the urban population in the northeast region of the United States who seek help for nicotine dependence. We expect our current population to have similar characteristics.
Who may be able to join
- Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence (excluding marijuana) or psychiatric diagnosis.
- Smoke at least 10 cigarettes per day for at least 6 months prior to study start date.
- Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control from at least 48 hours prior to SPECT imaging until 30 days following the scan. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, levonorgestrel implant, or complete abstinence.
- Subjects provide voluntary informed consent.
- Subjects must read on 8th grade (or above) level.
- Not using other methods for smoking cessation
Who cannot join
- Participation in clinical trial and receipt of investigational drug(s) during previous 60 days
- History of head trauma or injury causing loss of consciousness, lasting more than three (3) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
- HIV positive on medication for symptoms. This will be determined on an individual basis by results from the physical examination and final approval by our study physician.
- Symptomatic presence of other hematological disease.
- Clinically significant cardiovascular, hepatic (liver), renal (kidney), neurological, or endocrinological (including Type II diabetes) abnormalities.
- Asthmatic condition which requires the use of an inhaler more than twice per week
Show all 13Show fewer
- History of psychosis, seizures, or organic brain syndrome.
- Use of medications or natural herbs that may cause sedation or may effect the brain systems that are being studied (medication use will be evaluated by our study physician on a case-by-case basis).
- Claustrophobia, trypanophobia (needle phobia) or other medical condition preventing subject from lying in the SPECT scanner for approximately one (1) hour.
- Individuals with an intelligence quotient of 80 or less.
- Smoke non-filtered cigarettes
- Treatment for alcohol or drug dependence within the last 3 months
- A significant alcohol or drug use history (multiple treatments, 5 years of dependence, positive urines, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Addiction Treatment Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Use of SPECT (Single-photon Emission Computed Tomography) to Examine the Role of DAT (Dopamine Transporter) Genotype in Motivated Smoking Behavior
A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is available at the synapse and this may affect the underlying reasons for relapse in smokers. This research will use Single-photon emission computed tomography SPECT and the DAT-specific ligand, TRODAT (Dopamine Transporter Density by [99mTc]), to examine the availability of DAT in smokers grouped by genotype in the sated (just having smoked) and withdrawal (4 hours without smoking) conditions.
Read the detailed description
There will be 2 SPECT scans for each smoker who participates in this research. One SPECT scan when the smoker is sated with nicotine and one where the smoker is in withdrawal
- Conditions
- Nicotine Withdrawal
- Being tested
- TRODAT
- Keywords
- Smoker, SPECT, Dopamine, Nicotine Sated condition, Nicotine withdrawal condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRODATRadiation
Smoker will receive a TRODAT injection
| Study group | Role | What they receive |
|---|---|---|
| Sated and withdrawal group | To determine differences in TRODAT binding to the DAT between a smoker when sated and when in withdrawal Receives: Radiation: TRODAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT
To determine differences in TRODAT binding to the DAT between smokers who are sated and those who are in withdrawal
Measured: Up to 3 years for data analyses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionOct 2014
Why it stopped: UPenn suspended production of the ligand necessary to produce the tracer TRODAT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine WithdrawalStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Franklin, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492322
- Sponsor's protocol ID
- 813475
- Acronym
- DDAT
- Status last verified
- Dec 2011
- First submitted
- 2 Dec 2011
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of SPECT (Single-photon Emission Computed Tomography) to Examine the Role of DAT (Dopamine Transporter) Genotype in Motivated Smoking Behavior
- ClinicalTrials.gov ID
- NCT01492322
- Acronym / sponsor ID
- DDAT / 813475
- Conditions
- Nicotine Withdrawal
- Keywords
- Smoker, SPECT, Dopamine, Nicotine Sated condition, Nicotine withdrawal condition
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: UPenn suspended production of the ligand necessary to produce the tracer TRODAT.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Dec 2011 (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.
A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is available at the synapse and this may affect the underlying reasons for relapse in smokers. This research will use Single-photon emission computed tomography SPECT and the DAT-specific ligand, TRODAT (Dopamine Transporter Density by [99mTc]), to examine the availability of DAT in smokers grouped by genotype in the sated (just having smoked) and withdrawal (4 hours without smoking) conditions.
Detailed description
There will be 2 SPECT scans for each smoker who participates in this research. One SPECT scan when the smoker is sated with nicotine and one where the smoker is in withdrawal
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sated and withdrawal group | – | Radiation: TRODATTo determine differences in TRODAT binding to the DAT between a smoker when sated and when in withdrawal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects will be forty physically-healthy and mentally-stable male and non-pregnant female subjects between the ages of 18 and 60 who meet the DSM-IV criteria for nicotine dependence. Subjects will not be excluded based on gender, religion, race, or socioeconomic status. The subject population of previous smoking studies in our lab was 54% female, 62% Caucasian, and averaged 15 years of education. This is representative of the urban population in the northeast region of the United States who seek help for nicotine dependence. We expect our current population to have similar characteristics.
Key inclusion criteria (6 listed)
- Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence (excluding marijuana) or psychiatric diagnosis.
- Smoke at least 10 cigarettes per day for at least 6 months prior to study start date.
- Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control from at least 48 hours prior to SPECT imaging until 30 days following the scan. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, levonorgestrel implant, or complete abstinence.
- Subjects provide voluntary informed consent.
- Subjects must read on 8th grade (or above) level.
Key exclusion criteria (13 listed)
- Participation in clinical trial and receipt of investigational drug(s) during previous 60 days
- History of head trauma or injury causing loss of consciousness, lasting more than three (3) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
- HIV positive on medication for symptoms. This will be determined on an individual basis by results from the physical examination and final approval by our study physician.
- Symptomatic presence of other hematological disease.
- Clinically significant cardiovascular, hepatic (liver), renal (kidney), neurological, or endocrinological (including Type II diabetes) abnormalities.
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 |
|---|---|---|
| TRODATSmoker will receive a TRODAT injection | Radiation | Sated and withdrawal group |
Primary outcome
SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT
Time frame: Up to 3 years for data analyses
To determine differences in TRODAT binding to the DAT between smokers who are sated and those who are in withdrawal
Results and safety
The study was stopped early (reason given: UPenn suspended production of the ligand necessary to produce the tracer TRODAT.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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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.
Teresa Franklin, PhD principal investigator
University of Pennsylvania
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 Nicotine Withdrawal, run by University of Pennsylvania 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Oct 2015. 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 was stopped early (reason given: UPenn suspended production of the ligand necessary to produce the tracer TRODAT.). Results are not available in the source record.
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.
What does the primary outcome measure?
SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT (time frame: Up to 3 years for data analyses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2015.