CompletedNCT03384784CHIUpdated Oct 17, 2024Results posted

Effect of Galantamine on Inflammation and Cognition

A Phase 2 interventional study of Galantamine and Placebo in HIV Associated Cognitive Motor Complex, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 63
Allocation: Randomized
Ages: 30 Years and older
Sex: All

Study summary

This study tests whether galantamine (GAL) reduces HIV-related inflammation and cognitive deficits. In this double-blind placebo-controlled crossover study, HIV-infected individuals (N=120; 60 smokers and 60 non-smokers) will be randomized to 12 weeks of GAL or placebo, followed by a 4-week washout, then 12 weeks of GAL or placebo (arms switched). Outcomes are monocyte/macrophage and T cell activation and neurocognitive performance.

Read the detailed description

Although anti-retroviral therapy (ART) enhances life expectancy and overall quality of life (QoL), HIV-infected individuals are increasingly vulnerable to non-AIDS-related diseases including HIV-associated neurocognitive disorders (HAND). Inflammation is a primary mechanism in the pathogenesis of HAND and tobacco use may further exacerbate inflammation. Conversely, nicotine alone has anti-inflammatory effects suggesting that stimulating the cholinergic pathway via pharmacological treatment [e.g., galantamine (GAL)] may suppress inflammation and reverse or prevent neurocognitive deficits in HIV-1 infection. In this double-blind, placebo-controlled crossover study, HIV-infected individuals (N=120; 60 smokers, 60 nonsmokers) will be randomized to 12 weeks of GAL or placebo, followed by a 4-week washout, then 12 weeks of GAL or placebo (arms switched). All subjects will be stable on ART and the GAL dose will follow FDA guidelines. At the beginning and end of each treatment phase, inflammatory biomarkers and viral load will be assessed. Monocyte transcriptomics will also be assessed on a subset of the sample (n=60; 30/group). Neurocognition and clinical outcomes (e.g., QoL) will be measured at baseline and at 4-week intervals during each treatment phase. The primary outcomes are monocyte/macrophage and T-cell activation (CD16, CD163, and CC chemokine receptor type 2 or CCR2 expression; plasma CC chemokine ligand type 2 or CCL2 [MCP-1 or monocyte chemoattractant protein-1], sCD14; CD38/HLA-DR [cluster of differentiation 38/Human Leukocyte Antigen- antigen D Related] on CD8 [cluster of differentiation 8] cells) and neurocognitive performance (processing speed, verbal learning/memory, executive function). Exploratory outcomes include monocyte gene expression patterns and broad plasma cytokine analysis. This study will provide insight into the interactions among nAChR activation, HIV immune activation and pathogenesis, and tobacco use and has translational and therapeutic implications that could improve health outcomes among HIV-infected individuals.

Conditions studied

HIV Associated Cognitive Motor Complex

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Keywords

HIV
Neurocognition
Inflammation
Galantamine
Nicotine
Tobacco Use

Who can participate

Ages eligible: 30 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Eligible subjects will be males and females:

At least 30 years old
Diagnosed with HIV-1 infection
On stable ART regimens (no changes to treatment within 4 weeks of Intake visit)
Viral load of less than or equal to 200 copies/mL
Current cluster of differentiation (CD4) counts greater than 200
If current or past diagnosis of bipolar disorder, eligible if:
1. No psychotic features
2. Montgomery-Asberg Depression Rating Scale (MADRS): total score less than 8 (past 4 weeks), suicidal item score less than 1 (past 4 weeks)
3. Young Mania Rating Scale (Y-MRS): total score less than 8 (past 4 weeks), irritability, speech content, disruptive or aggressive behavior items score less than 3 (past 4 weeks)
4. No psychiatric hospitalization or Emergency Room visits for psychiatric issues in the past 6 months
5. No aggressive or violent acts or behavior in the past 6 months
Able to communicate in English and provide written informed consent
Will be residing in the geographic area for at least 7 months
Not currently trying to quit smoking
Smoking Status
1. Smokers (HIV+S) will report at least 5 instances of smoking per day, on average for the past year and provide a breath carbon monoxide (CO) sample greater than 5 ppm at Intake and at the beginning of each treatment period
2. Non-smokers (HIV+NS) will report smoking fewer than 100 cigarettes in their lifetime, or less than 5 pack years of smoking and no cigarettes in the last year. They will self-report no current use of any tobacco or nicotine product and will provide a CO sample of less than 3 ppm at Intake and at the beginning of each treatment period. If CO sample does not reflect self-report, the PI will be consulted to determine eligibility.

Exclusion criteria

Exclusion Criteria:

Subjects who present with and/or self-report the following criteria will not be eligible to participate in the study.

Smoking Behavior

Current enrollment or plans to enroll in another smoking cessation program in the next 7 months.
Regular (daily) use of electronic cigarettes, chewing tobacco, snuff, snus, cigars, cigarillos, or pipes.
Current use or plans to use nicotine substitutes (gum, patch, lozenge, e-cigarette) or smoking cessation treatments in the next 7 months.

Alcohol/Drug Use

Current untreated and unstable diagnosis of substance abuse or dependence (if past use and if receiving treatment and stable for at least 30 days, eligible)
Positive urine drug screen for cocaine, methamphetamines, phencyclidine (PCP), barbiturates, ecstasy (MDMA), at Intake or Lab visits. Those who screen positive for amphetamines, benzodiazepines, methadone, oxycodone, and/or opiates (low level cut-off 300 ng/mL) and who are prescribed these medications will be reviewed on a case-by-case basis by the study physician and PIs (see Measures and Table 1 for details). Participants believed to have a false-positive result on the drug screen may continue in the study, with investigator approval.

Medical/Psychiatric Conditions

Women who are pregnant, planning a pregnancy or lactating
Current diagnosis of unstable and untreated major depression (if stable for at least 30 days, eligible)
Current or past diagnosis of psychotic disorder
Cancer diagnosis within the past 6 months (except basal cell carcinoma)
Major heart disease or stroke within the past 6 months
Uncontrolled hypertension (systolic blood pressure greater than 160 or diastolic blood pressure greater than 100).
Medical conditions contraindicated for use with galantamine:
1. Diagnosis of Alzheimer's disease or dementia
2. Epilepsy or other seizure disorder
Bladder outflow obstruction
Active HCV co-infection (if cured, requires study physician approval)
Liver function tests more than 20% outside of the normal range; Gamma-glutamyl transpeptidase (GGT) values more than 20% outside of the normal range. If Albumin/Globulin ratios are 20% outside of normal range the abnormal value will be evaluated for clinical significance by the Study Physician and eligibility will determined on a case-by-case basis.
Renal disease or renal dysfunction (e.g., serum creatinine levels greater than 1.5 X upper limit of normal). Those with moderate hepatic impairment or creatinine clearance 9 to 59 mL/min shall not exceed the 16 mg/day dose.
Peptic ulcer disease (requires study physician approval)
Suicide risk as indicated by at least one of the following on the Columbia Suicide Severity Rating Scale (the PI and/or study psychologist will be consulted to assess safety and determine eligibility in cases close to the eligibility cutoffs):
1. Current suicidal ideation (within 30 days of enrollment)
2. Two or more lifetime suicide attempts or episodes of suicidal behavior
3. Any suicide attempt or suicidal behavior within 2 years of enrollment

Medication

Current use or discontinuation within the last 14 days of:
1. Quit smoking medications including varenicline (Chantix), bupropion (Wellbutrin)
2. Anti-psychotic medications (e.g., Zyprexa, Clozaril, Seroquel, Risperdal). If used to treat psychotic symptoms. Other uses may be eligible pending physician approval).
3. Systemic Steroids (e.g., Prednisone).
4. Alzheimer's disease medications (e.g., Acetylcholinesterase inhibitors (ACIs), Aricept/donepezil, Exelon/rivastigmine, Tacrine, or memantine)
5. Irritable bowel syndrome medication (e.g., Dicyclomine/Bentyl)
6. Heart medications (e.g., quinidine).
7. Muscle relaxants (e.g., Anectine/succinylcholine)
8. Anti-seizure medications (e.g. Ativan, Banzel, Carbatrol, Dilantin, Lamictal, Gabitril, Lyrica, Neurontin, Tegretol, Topomax) if used to treat a seizure disorder or epilepsy. Other uses may be eligible.
9. Urinary retention medications (e.g., Duvoid/bethanechol, Proscar/finasteride, Avodart/dutasteride, Dibenzyline/ phenoxybenzamine, Regitine/phentolamine)
Daily use of:
1. Opiate-containing medications for chronic pain (Duragesic/fentanyl patches, Percocet, Oxycontin). Smokers who report taking opiate-containing medications on an "as-needed" basis will be instructed to refrain from use until their study participation is over and that they will be tested to ensure they have complied with this requirement.
2. Chronic obstructive pulmonary disease (COPD) medication (e.g., Atrovent/Ipratropium Bromide)
Known allergy to study medication.

Subjects will be instructed to refrain from using any study prohibited drugs/medications (both recreational and prescription) throughout their participation in the study.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 63 participants (actual)

Study arms

Experimental
Galantamine first
This is a crossover study such that all participants receive both placebo and galantamine. Participants were randomized to receive galantamine first and placebo second. Timepoints Week 0 through Week 12 represent the first period and Weeks 16 through 28 represent the second period. This study follows the FDA-recommended dosing regimen for galantamine extended release (GAL ER): 4 weeks at 8 mg (once a day), 4 weeks at 16 mg (once a day), and 4 weeks at 24 mg (once a day). The University of Pennsylvania Investigational Drug Service (IDS) will oversee the randomization of all study medication, purchase study medication, manufacture matched placebo, encapsulate and package them in blister packs to maintain double-blind procedures.
Drug: Galantamine · Drug: Placebo
Placebo comparator
Placebo first
This is a crossover study such that all participants receive both placebo and galantamine. Participants were randomized to receive galantamine first and placebo second. Timepoints Week 0 through Week 12 represent the first period and Weeks 16 through 28 represent the second period. Placebo ingredients will be purchased, encapsulated, and packaged into blister packs by the IDS at the University of Pennsylvania. Both active medication and placebo will look identical. The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take galantamine during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by galantamine during the second medication period.
Drug: Galantamine · Drug: Placebo

Interventions

DrugGalantamine
The study will be performed using the 8mg, 16mg and 24mg doses of galantamine hydrobromide-ER. The dosing regimen will be an initial 4 weeks of drug run-up at the lowest 8mg q.d. dose, followed by 16mg q.d. for the following 4 weeks, and the dose will be increased for the last 4 weeks to 24mg. Participants will be instructed to take one 8mg 16mg or 24mg pill (galantamine-ER or placebo) every morning, preferably with food.
Also known as: Razadyne ER
DrugPlacebo
Matched placebo will be made in-house using lactulose filler in gel capsules. Participants will be instructed to take one pills every morning for 12 weeks.
Also known as: Sugar Pill

What researchers measure

Primary outcomes

Change in Cognition
Cognitive function will be assessed 4 times at Lab Visits. Executive function was measured by the task switch cost from the Color shape task, measured in ms. Executive function was also measured via response time (ms) and accuracy (# correct) on an N-back working memory task. Verbal learning and memory were measured by the Total Recall and Delayed Recall, respectively, from the Hopkins Verbal Learning Test. Response inhibition was measured by the stop signal reaction time (ms) from the Stop Signal Task. A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance. The primary outcome is the change from baseline cognitive function after 12 weeks of treatment. Change in cognition will be measured during each treatment arm.
Time frame: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Change in Inflammation (MCP-1)
Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.
Time frame: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)
Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.
Time frame: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Change in Inflammation (CD14)
Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.
Time frame: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)
Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.
Time frame: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)
Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.
Time frame: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)

Results

Posted Oct 17, 2024

Participant flow

First Intervention (12 Weeks)

Participant flow — First Intervention (12 Weeks)
Milestone	Galantamine First	Placebo First
Started	28	30
Completed	25	25
Not completed	3	5

Washout (4 Weeks)

Participant flow — Washout (4 Weeks)
Milestone	Galantamine First	Placebo First
Started	25	25
Completed	17	24
Not completed	8	1

Second Intervention (12 Weeks)

Participant flow — Second Intervention (12 Weeks)
Milestone	Galantamine First	Placebo First
Started	17	24
Completed	16	21
Not completed	1	3

Outcome measures

PrimaryChange in Cognition

Cognitive function will be assessed 4 times at Lab Visits. Executive function was measured by the task switch cost from the Color shape task, measured in ms. Executive function was also measured via response time (ms) and accuracy (# correct) on an N-back working memory task. Verbal learning and memory were measured by the Total Recall and Delayed Recall, respectively, from the Hopkins Verbal Learning Test. Response inhibition was measured by the stop signal reaction time (ms) from the Stop Signal Task. A composite score will be created by computed standardized z-scores for each measure (where the mean is 0 and the standard deviation is 1) and then averaging the z-scores. Measures of response time were reverse coded such that higher z-scores indicate better cognitive performance. The primary outcome is the change from baseline cognitive function after 12 weeks of treatment. Change in cognition will be measured during each treatment arm.

Time frame:: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:: Mean · Z-score

Change in Cognition
Z-score	Galantamine First	Placebo First
Period1 Lab 1 (Week 0)	.018 ± .469	.12 ± .509
Period 1 Lab 2 (Week 12)	0.068 ± 0.695	0.201 ± 0.615
Period 2 Lab 1 (Week 16)	0.020 ± 0.746	0.440 ± 0.578
Period 2 Lab 2 (Week 28)	0.219 ± 0.806	0.490 ± 0.472

PrimaryChange in Inflammation (MCP-1)

Cellular markers of immune activation will be measured in whole blood and soluble markers of immune activation will be measured in plasma at Lab Visits. The primary outcome is the change in monocyte and T cell surface activation and soluble markers after 12 weeks of treatment. Because this is a within-subject crossover study, changes in cellular markers will be measured during each treatment arm.

Time frame:: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:: Mean · pg/mL

Change in Inflammation (MCP-1)
pg/mL	Galantamine First	Placebo First
Period1 Lab 1 (Week 0)	405.00 ± 277.68	402.05 ± 206.56
Period1 Lab 2 (Week 12)	423.33 ± 266.71	337.01 ± 163.38
Period2 Lab 1 (Week 16)	411.71 ± 221.34	350.00 ± 149.55
Period2 Lab 2 (Week 28)	410.76 ± 300.29	334.91 ± 155.85

PrimaryChange in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)

Time frame:: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:: Mean · percentage of monocytes expressing CD8

Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD8)
percentage of monocytes expressing CD8	Galantamine First	Placebo First
Period1 Lab 1 (Week 0)	7.125 ± 6.859	5.590 ± 4.528
Period 1 Lab 2 (Week 12)	5.747 ± 5.789	5.221 ± 3.069
Period 2 Lab 1 (Week 16)	4.329 ± 2.933	6.570 ± 6.738
Period 2 Lab 2 (Week 28)	6.150 ± 5.257	6.916 ± 4.658

PrimaryChange in Inflammation (CD14)

Time frame:: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:: Mean · ng/ml

Change in Inflammation (CD14)
ng/ml	Galantamine First	Placebo First
Period1 Lab 1 (Week 0)	1672.64 ± 440.69	1645.42 ± 741.79
Period 1 Lab 2 (Week 12)	1807.66 ± 461.12	1512.70 ± 498.86
Period 2 Lab 1 (Week 16)	1809.55 ± 330.04	1517.90 ± 515.77
Period 2 Lab 2 (Week 28)	1631.96 ± 352.70	1521.68 ± 480.99

PrimaryChange in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)

Time frame:: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:: Mean · percentage of monocytes expressing CD163

Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD163)
percentage of monocytes expressing CD163	Galantamine First	Placebo First
Period1 Lab 1 (Week 0)	88.68 ± 5.48	89.11 ± 6.99
Period 1 Lab 2 (Week 12)	80.03 ± 20.67	83.90 ± 17.87
Period 2 Lab 1 (Week 16)	86.64 ± 7.67	87.15 ± 8.95
Period 2 Lab 2 (Week 28)	86.44 ± 5.06	90.94 ± 5.24

PrimaryChange in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)

Time frame:: Period1 Lab 1 (Week 0), Period 1 Lab 2 (Week 12), Period 2 Lab 1 (Week 16), Period 2 Lab 2 (Week 28)
Reported as:: Mean · percentage of monocytes expressing CD16

Change in Inflammation (Percentage of CD14+ Monocytes Expressing CD16)
percentage of monocytes expressing CD16	Galantamine First	Placebo First
Period1 Lab 1 (Week 0)	64.18 ± 19.49	64.90 ± 20.14
Period 1 Lab 2 (Week 12)	67.44 ± 17.88	68.02 ± 17.79
Period 2 Lab 1 (Week 16)	74.78 ± 15.27	69.04 ± 17.37
Period 2 Lab 2 (Week 28)	67.83 ± 13.23	59.78 ± 21.14

Adverse events

Collected over 28 weeks: From the start of treatment through the end of treatment. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Galantamine 8mg	1/52 (1.9%)	1/52 (1.9%)	2/52 (3.8%)
Galantamine 16mg	0/49 (0%)	0/49 (0%)	4/49 (8.2%)
Galantamine 24mg	0/48 (0%)	2/48 (4.2%)	2/48 (4.2%)
Placebo	0/47 (0%)	2/47 (4.3%)	3/47 (6.4%)

Most frequent serious events

Most frequent serious events
Event	Galantamine 8mg	Galantamine 16mg	Galantamine 24mg	Placebo
Gastrointestinal BleedingGastrointestinal disorders	0/52	0/49	1/48	1/47
Pulled muscleMusculoskeletal and connective tissue disorders	0/52	0/49	0/48	1/47
Low HemoglobinBlood and lymphatic system disorders	0/52	0/49	1/48	0/47
Bone fractureMusculoskeletal and connective tissue disorders	1/52	0/49	0/48	0/47

Most frequent other events

Most frequent other events
Event	Galantamine 8mg	Galantamine 16mg	Galantamine 24mg	Placebo
FatigueGeneral disorders	1/52	4/49	1/48	1/47
DepressionPsychiatric disorders	1/52	2/49	1/48	2/47
NauseaGastrointestinal disorders	0/52	0/49	0/48	2/47

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Galantamine First	Placebo First	Total
<=18 years	0	0	0
Between 18 and 65 years	28	30	58
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Galantamine First	Placebo First	Total
Mean	57.9 ± 3.7	57.3 ± 5.1	57.6 ± 4.4

Sex: Female, Male
Sex: Female, Male(Participants)	Galantamine First	Placebo First	Total
Female	5	8	13
Male	23	22	45

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Galantamine First	Placebo First	Total
Hispanic or Latino	3	1	4
Not Hispanic or Latino	25	29	54
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Galantamine First	Placebo First	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	21	19	40
White	4	10	14
More than one race	1	0	1
Unknown or Not Reported	2	1	3

Region of Enrollment
Region of Enrollment(participants)	Galantamine First	Placebo First	Total
United States	28	30	58

Smoking History
Smoking History(Participants)	Galantamine First	Placebo First	Total
Non-Smoker	10	22	32
Current Smoker	18	8	26

CD4 Levels at Intake
CD4 Levels at Intake(cells/microliter)	Galantamine First	Placebo First	Total
Mean	769.8 ± 311.2	611.6 ± 201.1	687.9 ± 269.7

1 further baseline measures are reported on the registry.

Study locations

1 site

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

References and documents

Study documents

Protocol and statistical analysis plan · Feb 22, 2021
Informed consent form · Feb 22, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The final dataset will include demographic and behavioral assessments and laboratory data bio-specimens. Because the dataset will contain personal health information, identifying information will be collected. Even though the final dataset will be stripped of identifiers prior to release for sharing, investigators will do the following to reduce the possibility confidentiality loss. We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Transcriptomic data will be deposited with a public access database such as NCBI's Gene Expression Omnibus (GEO) database (http://www.ncbi.nlm.nih.gov/geo/)

Supporting information: Study protocol, Sap, Icf

Registry details

Key details

Study ID: NCT03384784
Lead sponsor: University of Pennsylvania
Collaborators: National Institute on Drug Abuse (NIDA)
Responsible party: Sponsor
First posted: Dec 27, 2017
Start date: Oct 30, 2017
Primary completion: May 31, 2022
Completion: May 31, 2022
Results posted: Oct 17, 2024
Last update: Oct 17, 2024

Study contacts

Rebecca L Ashare, PhD

principal investigator · University of Pennsylvania

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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