Cocaine AbuseEarly Phase 1NCT02233829
Dopamine Rhythms in Health and Addiction
A Early Phase 1 study testing Brain Dopamine Reactivity and Brain Dopamine Receptor in people with Cocaine Abuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
Background: Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make these effects sensitive to the time of day they are taken. Cocaine can affect these genes in the brain. Researchers want to measure brain dopamine at different times of day. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Cocaine Abuse
- What is being tested?
- Brain Dopamine Reactivity and Brain Dopamine Receptor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2024to 23 Apr 2024
- Phase
- Early Phase 1
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 21 and 55 years of age.
- Ability to provide written informed consent.
- INCLUSION CRITERIA - SPECIFIC FOR COCAINE USE DISORDER (CUD) PARTICIPANTS:
- DSM-IV or DSM-5 diagnosis of a moderate or severe cocaine use disorder established through history and clinical exam.
- Non-treatment seeking cocaine users (actively consuming cocaine - last use within one week of study as assessed by self-reports).
- Minimum 10 years history of cocaine abuse predominantly via smoking or injection - self-report.
- Must consume at least 4 grams of cocaine per week - self-report.
Who cannot join
- Unwilling or unable to refrain from use within 24 hours of scheduled study procedures: psychoactive medications or medications that may affect study results e.g., antibiotics (must finish course at least 24 hours prior to a scheduled procedure), antidiarrheal preparations, anti-inflammatory drugs [systemic corticosteroids are exclusionary], anti-nausea, cough/cold preparations) (self-report, medical history). The following medications are allowable for entry on this study: analgesics (non-narcotic and narcotic for OUD participants); antacids; antiasthma agents that are not systemic corticosteroids; antifungal agents for topical use; antihistamines (non-sedating); H2-Blockers/PPI (proton pump inhibitors); laxatives. The use of antihyperlipidemics and/or diuretics are permitted if they have been taken for at least 1 month before procedure visits and dose has been stabilized as determined by medical history and physical exam. The episodic use of benzodiazepines such as alprazolam ((TM)Xanax), diazepam ((TM)Valium) and lorazepam ((TM)Ativan), will not exclude participants from this study unless they have been taken within the last 24 hours prior to the study.
- Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder (other than cocaine for the cocaine abusers, and nicotine/caffeine for any of the participants) that required hospitalization (any length), or chronic medication management (more than 4 weeks) and that could impact brain function at the time of the study as determined by history and clinical exam.
- The following current chronically used medications are exclusionary from the study: stimulant or stimulant-like medications (amphetamine, methylphenidate, modafinil) ; analgesics containing narcotics (for controls only); anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; antibiotics; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antidiarrheal preparations; antifungal agents (systemic); antihistamines (sedating); antihypertensives; anti-inflammatory drugs (systemic); antineoplastics; antiobesity; antipsychotics; antivirals (except for treatment of HSV with agents without CNS activity, e.g. acyclovir, ganciclovir, famciclovir, valacyclovir); anxiolytics (benzodiazepine or barbiturates); hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics. Note that nicotine and/or caffeine use will not exclude participants and that the use of cocaine will not exclude participants with CUD.
- Major medical problems that can permanently impact brain function (e.g., CNS including seizures and psychosis; cardiovascular including hypertension [BP > 140/90] and clinically significant arrhythmias except bradycardia; metabolic, autoimmune, endocrine; +HIV) as determined by history.
- Any clinically significant laboratory finding as determined during the screening procedures that could impact brain function or study procedures as evidenced from clinical laboratory results. Since half of the participants in the study will have a diagnosis of cocaine use disorder (CUD), we expect some clinically significant findings that would reflect their recent cocaine use. As an example, a participant might have a mildly elevated Creatinine Kinase as a result of recent cocaine use. The test would reflect an acute rhabdomyolysis due to recent cocaine use, and it would be clinically significant. Nevertheless, if it is a mild episode as expected with cocaine use, it would not affect brain functioning or increase the risk of the procedures for the participants in the study. Therefore, not all abnormal laboratory findings that have clinical significance will be excluded. If a finding reflects altered brain function (e.g., arrhythmias or renal failure) it will be exclusionary for the study.
- Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.
Show all 22Show fewer
- Head trauma with loss of consciousness for more than 30 minutes as determined by medical history and physical exam.
- Pregnant or breast feeding: Females must have negative urine pregnancy test and are not currently breastfeeding. Post-menopausal or surgically sterile (tubal ligation or hysterectomy); or not sexually active with a male partner and able to get pregnant; or documented agreement to use an effective form of birth control. Acceptable forms of contraception include: hormonal contraceptives (birth-control pills, injectable hormones, vaginal-ring hormones); IUD; diaphragm with spermicide; condom with spermicide.
- History of coagulation disorder as evidenced from clinical laboratory results, medical history.
- History of glaucoma as determined by medical history. Since glaucoma is screened for clinically at about the age of 40, any subjects 40 or older will undergo a glaucoma screening test if they have not been tested by their primary care physician. A result of 21 mmHg or higher will exclude.
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces - self-report checklist.
- Personal or family history for cerebral aneurism.
- Past or present history of chest pain and trouble breathing with activity.
- Diabetes as assessed by medical history.
- High risk for silent heart diseases as evidenced by high levels of high-sensitivity C-reactive protein or homocysteine in blood, or being overweight or obese. In addition patients with high cholesterol or a family history of heart disease will be evaluated by a cardiologist to determine their eligibility for participation. The cardiologist might request additional tests if he deems it necessary to ensure fitness for participation (ie treadmill stress test). Specifically the cardiologist involved will review the findings of 1) an inability to reach these endpoints, 2) the development of chest pain, 3) significant ST segment changes, 4) significant arrhythmias, and 5) an inability to appropriately increase blood pressure or heart rate with exercise in order to determine if the participant is suitable for inclusion in the study.
- Cannot lie comfortably flat on your back for up to 2 hours in the PET and MRI scanners - self-report.
- Weight > 400 pounds which is the maximum weight the PET scanner can hold.
- Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings).
- Note that subjects will not be excluded from enrollment onto this study if their urine test is positive for drugs on initial screening. The following guidelines will be followed for positive drug screens on study procedure days:
- If a Healthy Volunteer subject s urine drug screen test is positive on days involving imaging (MRI and/or PET) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive urine drug screens. If the drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study.
- If a CUD subject s urine drug screen test is positive for drugs (except cocaine), the procedures will be postponed and rescheduled to another day. We will not place a limit on rescheduling study days in this participant group.
- Note: At any time a subject expresses that he/she wants to get treatment for their cocaine use, we will immediately refer him/her to a treatment program. The subject will be withdrawn from the study at that time.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make these effects sensitive to the time of day they are taken. Cocaine can affect these genes in the brain. Researchers want to measure brain dopamine at different times of day.
Read more
Objectives:
- To look for changes to a person s biological clock in the function of the dopamine reward system. To test if cocaine disrupts this.
Eligibility:
- Adults age 21-55 with a cocaine use disorder.
- Healthy volunteers age 21-55.
Design:
- Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking.
- Participants will have 3 overnight clinic visits.
- Visit 1: They will have blood and urine collected and a heart test.
- A plastic tube (catheter) will be placed into a vein in each arm by needle.
- Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug (blocks dopamine removal) will be injected via catheter. Vital signs will be measured and blood will be drawn throughout.
- Visit 2: repeats Visit 1, except at night.
- Visit 3, participants will have urine collected.
- They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will lie on a table that slides in and out of it, with a coil over their head.
- Participants may answer questions, take computer or paper tests, and perform simple actions.
- For 1 week, participants will wear a wrist device that measures daily activity.
Read the detailed description
Objectives:
The primary objective is to assess if there is disruption of circadian DA rhythms in cocaine addiction. The secondary objective is to assess if dopamine modulates the sensitivity of the brain reward network in a circadian dependent manner.
Study Population:
Non-treatment seeking cocaine abusers (moderate or severe cocaine use disorder as per DSM-IV or DSM 5) and healthy controls. Males and females will be included.
Design:
Participants will undergo two PET scans with [11C]raclopride using a bolus infusion paradigm to assess baseline D2R availability followed by an infusion to assess changes in DA as measured by [11C]raclopride s displacement following an intravenous injection of methylphenidate (MP). They will also undergo a total of 4 MRI scans, two after placebo and two after MP to assess the circadian variations in the sensitivity of the brain reward network. The two [11C]raclopride scans will be done on separate days at least one week apart, one in the morning starting between (7-9 AM) and one in the early evening (5-7 PM) and they will be followed by an MRI scan to assess the sensitivity of the brain reward network under the influence of MP in the morning (9-11AM) and in the evening (7-9 PM). For the Placebo MRI scans participants will be tested either on separate days or on the morning of the evening session or on the evening prior to the morning session. We will use the MRI scans to assess the sensitivity of the brain reward circuit to visual presentation of drug or food cues and to evaluate resting functional connectivity.
Outcome Parameters:
Main outcome measure is to assess if there are differences in DA release between the morning and the evening (displacement of [11C]raclopride binding after MP) and to determine if these diurnal patterns differ in cocaine addiction. Secondary outcome measures are: To assess if DA signaling correlates with reactivity of brain regions to exposure of food and drug cues and with functional connectivity of the reward network and to assess if the reactivity of the reward network shows circadian variability. We will also assess if differences in DA signaling between morning and evening correlate with circadian typology and with measures of spontaneous motor activity and with sleeping patterns.
- Conditions
- Cocaine Abuse
- Being tested
- Brain Dopamine Reactivity, Brain Dopamine Receptor
- Keywords
- C-11 Raclopride, PET, Circadian Rhythm
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Dopamine ReactivityDrug
IV methylphenidate, used under IND #124, 912 is injected into the subject s bloodstream to be used in conjunction with PET imaging to show displacement of [11C]raclopride.
Brain Dopamine ReceptorRadiation
The radiotracer [11C] raclopride is used for imaging dopamine receptors and dopamine release.
| Study group | Role | What they receive |
|---|---|---|
| Evening MRI/PET/Raclopride/IV Methylphenidate Session | Active comparator | The PET [11C] raclopride scan will be done between 5-7 PM. After iv catheters are inserted blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plus-infusion method for [11C]raclopride and the administration of intravenous MP (0.5 mg/kg) forty-five minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes. Receives: Drug: Brain Dopamine Reactivity; Radiation: Brain Dopamine Receptor |
| Morning MRI/PET/Raclopride/IV Methylphenidate Session | Active comparator | Morning Session [11C]raclopride PET scan: To be started between 7-8 AM. After iv catheters are inserted, genetic blood samples are drawn and then blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plusinfusion method for [11C]raclopride and the administration of intravenous MP (0.25 mg/kg) fortyfive minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes. Receives: Drug: Brain Dopamine Reactivity; Radiation: Brain Dopamine Receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if there is disruption in circadian rhythms in cocaine use disorder (CUD) as compared to healthy controls.
To assess if there are diurnal rhythms in DA signaling and in reward brain circuits and to determine if these are disrupted in cocaine addiction.
Measured: end of study
Secondary outcomes (3)
Measuring dopamine signaling
To assess if DA signaling correlates with reactivity of brain reward regions to exposure of drug and with functional connectivity of thereward network and to assess if the reactivity of reward network shows circadian variability.
Measured: end of study
Measuring circadian typology
To determine if differences in the measures of DA signaling between morning and evening correlate with circadian typology.
Measured: end of study
Measuring sleep patterns
To determine if measures of DA signaling correlate with measures of spontaneous motor activity and with sleeping patterns.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start23 Apr 2024
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Why it stopped: No enrollment, delay with drug availability.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cocaine 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gene-Jack Wang, M.D., Principal investigator, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233829
- Sponsor's protocol ID
- 140187
- Other IDs
- 14-AA-0187
- Status last verified
- Apr 2024
- First submitted
- 6 Sep 2014
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: .Data is analyzed by subject group and not on an individual basis.
Publications
Wang GJ, Volkow ND, Fowler JS, Logan J, Pappas NR, Wong CT, Hitzemann RJ, Netusil N. Reproducibility of repeated measures of endogenous dopamine competition with [11C]raclopride in the human brain in response to methylphenidate. J Nucl Med. 1999 Aug;40(8):1285-91.
PubMed 10450679Wang GJ, Volkow ND, Logan J, Pappas NR, Wong CT, Zhu W, Netusil N, Fowler JS. Brain dopamine and obesity. Lancet. 2001 Feb 3;357(9253):354-7. doi: 10.1016/s0140-6736(00)03643-6.
PubMed 11210998Dunn JP, Cowan RL, Volkow ND, Feurer ID, Li R, Williams DB, Kessler RM, Abumrad NN. Decreased dopamine type 2 receptor availability after bariatric surgery: preliminary findings. Brain Res. 2010 Sep 2;1350:123-30. doi: 10.1016/j.brainres.2010.03.064. Epub 2010 Mar 31.
PubMed 20362560
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine Rhythms in Health and Addiction
- ClinicalTrials.gov ID
- NCT02233829
- Acronym / sponsor ID
- 140187
- Conditions
- Cocaine Abuse
- Keywords
- C-11 Raclopride, PET, Circadian Rhythm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment, delay with drug availability.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 9 Sep 2014 (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.
Background:
- Dopamine is a chemical signal linked to the rewarding effects of drugs. Certain genes make these effects sensitive to the time of day they are taken. Cocaine can affect these genes in the brain. Researchers want to measure brain dopamine at different times of day.
Objectives:
- To look for changes to a person s biological clock in the function of the dopamine reward system. To test if cocaine disrupts this.
Eligibility:
- Adults age 21-55 with a cocaine use disorder.
- Healthy volunteers age 21-55.
Design:
- Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking.
- Participants will have 3 overnight clinic visits.
- Visit 1: They will have blood and urine collected and a heart test.
- A plastic tube (catheter) will be placed into a vein in each arm by needle.
- Participants will have a PET scan in a donut-shaped machine. They will lie on a bed that slides in and out of it, wearing a cap. A radiotracer (measures dopamine) and a drug (blocks dopamine removal) will be injected via catheter. Vital signs will be measured and blood will be drawn throughout.
- Visit 2: repeats Visit 1, except at night.
- Visit 3, participants will have urine collected.
- They will have MRI scans in a metal cylinder surrounded by a magnetic field. They will lie on a table that slides in and out of it, with a coil over their head.
- Participants may answer questions, take computer or paper tests, and perform simple actions.
- For 1 week, participants will wear a wrist device that measures daily activity.
Detailed description
Objectives:
The primary objective is to assess if there is disruption of circadian DA rhythms in cocaine addiction. The secondary objective is to assess if dopamine modulates the sensitivity of the brain reward network in a circadian dependent manner.
Study Population:
Non-treatment seeking cocaine abusers (moderate or severe cocaine use disorder as per DSM-IV or DSM 5) and healthy controls. Males and females will be included.
Design:
Participants will undergo two PET scans with [11C]raclopride using a bolus infusion paradigm to assess baseline D2R availability followed by an infusion to assess changes in DA as measured by [11C]raclopride s displacement following an intravenous injection of methylphenidate (MP). They will also undergo a total of 4 MRI scans, two after placebo and two after MP to assess the circadian variations in the sensitivity of the brain reward network. The two [11C]raclopride scans will be done on separate days at least one week apart, one in the morning starting between (7-9 AM) and one in the early evening (5-7 PM) and they will be followed by an MRI scan to assess the sensitivity of the brain reward network under the influence of MP in the morning (9-11AM) and in the evening (7-9 PM). For the Placebo MRI scans participants will be tested either on separate days or on the morning of the evening session or on the evening prior to the morning session. We will use the MRI scans to assess the sensitivity of the brain reward circuit to visual presentation of drug or food cues and to evaluate resting functional connectivity.
Outcome Parameters:
Main outcome measure is to assess if there are differences in DA release between the morning and the evening (displacement of [11C]raclopride binding after MP) and to determine if these diurnal patterns differ in cocaine addiction. Secondary outcome measures are: To assess if DA signaling correlates with reactivity of brain regions to exposure of food and drug cues and with functional connectivity of the reward network and to assess if the reactivity of the reward network shows circadian variability. We will also assess if differences in DA signaling between morning and evening correlate with circadian typology and with measures of spontaneous motor activity and with sleeping patterns.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Evening MRI/PET/Raclopride/IV Methylphenidate Session | Active comparator | Drug: Brain Dopamine Reactivity, Radiation: Brain Dopamine ReceptorThe PET [11C] raclopride scan will be done between 5-7 PM. After iv catheters are inserted blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plus-infusion method for [11C]raclopride and the administration of intravenous MP (0.5 mg/kg) forty-five minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes. |
| Morning MRI/PET/Raclopride/IV Methylphenidate Session | Active comparator | Drug: Brain Dopamine Reactivity, Radiation: Brain Dopamine ReceptorMorning Session [11C]raclopride PET scan: To be started between 7-8 AM. After iv catheters are inserted, genetic blood samples are drawn and then blood sampling starts and continues throughout study. Cardiac monitoring is initiated and continues until physician discontinues post PET scan. Bolus-plusinfusion method for [11C]raclopride and the administration of intravenous MP (0.25 mg/kg) fortyfive minutes after initial bolus injection of [11C]raclopride. Scan to be done for a total of 100 minutes. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- DSM-IV or DSM-5 diagnosis of a moderate or severe cocaine use disorder established through history and clinical exam.
- Non-treatment seeking cocaine users (actively consuming cocaine - last use within one week of study as assessed by self-reports).
- Minimum 10 years history of cocaine abuse predominantly via smoking or injection - self-report.
- Must consume at least 4 grams of cocaine per week - self-report.
Key exclusion criteria (22 listed)
- Unwilling or unable to refrain from use within 24 hours of scheduled study procedures: psychoactive medications or medications that may affect study results e.g., antibiotics (must finish course at least 24 hours prior to a scheduled procedure), antidiarrheal preparations, anti-inflammatory drugs [systemic corticosteroids are exclusionary], anti-nausea, cough/cold preparations) (self-report, medical history). The following medications are allowable for entry on this study: analgesics (non-narcotic and narcotic for OUD participants); antacids; antiasthma agents that are not systemic corticosteroids; antifungal agents for topical use; antihistamines (non-sedating); H2-Blockers/PPI (proton pump inhibitors); laxatives. The use of antihyperlipidemics and/or diuretics are permitted if they have been taken for at least 1 month before procedure visits and dose has been stabilized as determined by medical history and physical exam. The episodic use of benzodiazepines such as alprazolam ((TM)Xanax), diazepam ((TM)Valium) and lorazepam ((TM)Ativan), will not exclude participants from this study unless they have been taken within the last 24 hours prior to the study.
- Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder (other than cocaine for the cocaine abusers, and nicotine/caffeine for any of the participants) that required hospitalization (any length), or chronic medication management (more than 4 weeks) and that could impact brain function at the time of the study as determined by history and clinical exam.
- The following current chronically used medications are exclusionary from the study: stimulant or stimulant-like medications (amphetamine, methylphenidate, modafinil) ; analgesics containing narcotics (for controls only); anorexics (sibuteramine); antianginal agents; antiarrhythmics; antiasthma agents that are systemic corticosteroids; antibiotics; anticholinergics; anticoagulants; anticonvulsants; antidepressants; antidiarrheal preparations; antifungal agents (systemic); antihistamines (sedating); antihypertensives; anti-inflammatory drugs (systemic); antineoplastics; antiobesity; antipsychotics; antivirals (except for treatment of HSV with agents without CNS activity, e.g. acyclovir, ganciclovir, famciclovir, valacyclovir); anxiolytics (benzodiazepine or barbiturates); hormones (exceptions: thyroid hormone replacement, oral contraceptives, and estrogen replacement therapy); insulin; lithium; muscle relaxants; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics. Note that nicotine and/or caffeine use will not exclude participants and that the use of cocaine will not exclude participants with CUD.
- Major medical problems that can permanently impact brain function (e.g., CNS including seizures and psychosis; cardiovascular including hypertension [BP > 140/90] and clinically significant arrhythmias except bradycardia; metabolic, autoimmune, endocrine; +HIV) as determined by history.
- Any clinically significant laboratory finding as determined during the screening procedures that could impact brain function or study procedures as evidenced from clinical laboratory results. Since half of the participants in the study will have a diagnosis of cocaine use disorder (CUD), we expect some clinically significant findings that would reflect their recent cocaine use. As an example, a participant might have a mildly elevated Creatinine Kinase as a result of recent cocaine use. The test would reflect an acute rhabdomyolysis due to recent cocaine use, and it would be clinically significant. Nevertheless, if it is a mild episode as expected with cocaine use, it would not affect brain functioning or increase the risk of the procedures for the participants in the study. Therefore, not all abnormal laboratory findings that have clinical significance will be excluded. If a finding reflects altered brain function (e.g., arrhythmias or renal failure) it will be exclusionary for the study.
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 |
|---|---|---|
| Brain Dopamine ReactivityIV methylphenidate, used under IND #124, 912 is injected into the subject s bloodstream to be used in conjunction with PET imaging to show displacement of [11C]raclopride. | Drug | Evening MRI/PET/Raclopride/IV Methylphenidate Session, Morning MRI/PET/Raclopride/IV Methylphenidate Session |
| Brain Dopamine ReceptorThe radiotracer [11C] raclopride is used for imaging dopamine receptors and dopamine release. | Radiation | Evening MRI/PET/Raclopride/IV Methylphenidate Session, Morning MRI/PET/Raclopride/IV Methylphenidate Session |
Primary outcome
To determine if there is disruption in circadian rhythms in cocaine use disorder (CUD) as compared to healthy controls.
Time frame: end of study
To assess if there are diurnal rhythms in DA signaling and in reward brain circuits and to determine if these are disrupted in cocaine addiction.
3 secondary outcomes
Measuring dopamine signaling
Time frame: end of study
Measuring circadian typology
Time frame: end of study
Measuring sleep patterns
Time frame: end of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 10450679Wang GJ, Volkow ND, Fowler JS, Logan J, Pappas NR, Wong CT, Hitzemann RJ, Netusil N. Reproducibility of repeated measures of endogenous dopamine competition with [11C]raclopride in the human brain in response to methylphenidate. J Nucl Med. 1999 Aug;40(8):1285-91.
- Background: PubMed 11210998Wang GJ, Volkow ND, Logan J, Pappas NR, Wong CT, Zhu W, Netusil N, Fowler JS. Brain dopamine and obesity. Lancet. 2001 Feb 3;357(9253):354-7. doi: 10.1016/s0140-6736(00)03643-6.
- Background: PubMed 20362560Dunn JP, Cowan RL, Volkow ND, Feurer ID, Li R, Williams DB, Kessler RM, Abumrad NN. Decreased dopamine type 2 receptor availability after bariatric surgery: preliminary findings. Brain Res. 2010 Sep 2;1350:123-30. doi: 10.1016/j.brainres.2010.03.064. Epub 2010 Mar 31.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. .Data is analyzed by subject group and not on an individual basis.
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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.
Gene-Jack Wang, M.D. principal investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Brain Dopamine Reactivity and Brain Dopamine Receptor in people with Cocaine Abuse, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) 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 7 inclusion and 22 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: withdrawn, as of the sponsor's last update on 24 Apr 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To determine if there is disruption in circadian rhythms in cocaine use disorder (CUD) as compared to healthy controls. (time frame: end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233829, which also lists 3 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 24 Apr 2024.