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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA044878 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.
In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| O-BMT (onsite treatment) | Experimental | Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment |
|
| Enhanced Referral | Active Comparator | In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onsite treatment | Behavioral | Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy. |
| Measure | Description | Time Frame |
|---|---|---|
| Buprenorphine Engagement | Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm. | 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Retention | Treatment retention was assessed by the number/percentage of participants who had a medical visit AND active buprenorphine prescription each month after buprenorphine initiation for 6 months. Results are summarized by study arm. | 6 months |
| HIV Risk Behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Fox, MD, MS | Associate Professor of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Heights CORNER Project | New York | New York | 10033 | United States | ||
| New York Harm Reduction Educators |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34990854 | Background | Perez-Correa A, Abbas B, Riback L, Ghiroli M, Norton B, Murphy S, Jakubowski A, Hayes BT, Cunningham CO, Fox AD. Onsite buprenorphine inductions at harm reduction agencies to increase treatment engagement and reduce HIV risk: Design and rationale. Contemp Clin Trials. 2022 Mar;114:106674. doi: 10.1016/j.cct.2021.106674. Epub 2022 Jan 3. |
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211 participants were screened and 97 were randomized into the study. Of the 114 participants who were not enrolled into the study, 98 participants did not meet all of the eligibility criteria, 13 did not show up for the enrollment visit and 3 participants signed the informed consent form but were not randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | O-BMT (Onsite Treatment) | Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy. Buprenorphine: all participants will receive buprenorphine |
| FG001 | Enhanced Referral | In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment Buprenorphine: all participants will receive buprenorphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | O-BMT (Onsite Treatment) | Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy. Buprenorphine: all participants will receive buprenorphine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Buprenorphine Engagement | Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm. | Intention to treat (ITT) analysis design. All participants, including those who are lost to follow-up, are included in the analysis. | Posted | Count of Participants | Participants | 30 days after randomization |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | O-BMT (Onsite Treatment) | Over 2 weeks at the syringe-exchange program, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment Onsite treatment: Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy. Buprenorphine: all participants will receive buprenorphine |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Opioid Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment | Pt overdosed on opioids while at syringe exchange program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma Attack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aaron D. Fox, Professor, General Internal Medicine | Montefiore Medical Center | 718-920-7173 | adfox@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2020 | Dec 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2024 | Dec 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral
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| Enhanced referral | Behavioral | Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment |
|
| Buprenorphine | Drug | all participants will receive buprenorphine |
|
Change in HIV risk behaviors will be assessed using the HIV risk behavior survey. This survey, consisting of a dichotomous (yes/no) measure of injection risk, will be used based on self-report of at least one risk behavior (sharing syringes, not using bleach to clean syringes, sharing cookers, or front/back loading of syringes) reported during the interval. The number of participants demonstrating at least one risk behavior is during the 6 month interval is summarized by study arm. |
| 6 months |
| Buprenorphine Diversion | Buprenorphine diversion will be defined as having at least one problem behavior: non-adherence to prescribed medication on electronic monitoring, self-reported diversion, or a urine sample consistent with diversion during the 6 month interval. This outcome measure is used to determine how many participants sell or give away prescribed medication. The number of participants with at least one problem behavior is summarized by study arm. | 6 months |
| Incremental Cost-effectiveness Ratio (ICER) | The ICER will be calculated by dividing the incremental mean cost of the O-BMT arm relative to the control arm by the incremental mean effectiveness of the O-BMT arm relative to the control arm. The primary economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. ICER is a composite measure that incorporates QALYs (also reported as a separate outcome measure) and mean costs (also reported as a separate outcome measure). | 6 months |
| Quality-adjusted Life-years (QALYs) Gained | The main economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. Mean years gained are summarized by study arm. | 6 months |
| Mean Difference in Total Costs | Mean cost (in US dollars) of the O-BMT arm were compared to the control arm. The resource utilization and resulting cost of implementing and administering the O-BMT intervention were estimated using microcosting analysis and participant self-report. Mean costs (in US dollars) are summarized by study arm. | 6 months |
| Time to First Buprenorphine Prescription | Time to first buprenorphine prescription is defined as the amount of time, in days, from when a participant enrolled in the study to receipt of first buprenorphine prescription. Results are summarized by study arm using basic descriptive statistics. | 1 month |
| Number/Percentage of Participants Who Received Any Buprenorphine Prescription | The Number/percentage of participants who received any buprenorphine prescription is defined as the number/percentage of participants that filled at least one prescription for buprenorphine while enrolled in the study. Results are summarized by study arm. | 6 months |
| Total Time Prescribed Buprenorphine | Total time prescribed buprenorphine is defined as the amount of time in days that participants were prescribed buprenorphine during the study period. Results are summarized by study arm using basic descriptive statistics. | 6 months |
| New York |
| New York |
| 10035 |
| United States |
| BOOM!Health Harm Reduction Center | The Bronx | New York | 10451 | United States |
| BG001 | Enhanced Referral | In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment Buprenorphine: all participants will receive buprenorphine |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mental Health Condition | Mental health condition was assessed at baseline based on participant response to a survey question as to whether they have ever been diagnosed with a serious mental illness. The percentage of participants who responded "Yes" to having been diagnosed with a mental health condition is summarized by study arm. | Count of Participants | Participants |
|
| Intravenous Drug Use | Prior intravenous (IV) drug use was assessed at baseline by participant response to a dichotomous (Yes/No) query regarding previous IV drug use over the prior 30-day period. The percentage of participants who responded "Yes" to prior IV use is summarized by study arm. | Count of Participants | Participants |
|
| Buprenorphine Use | Prior Buprenorphine use was determined at baseline by participant response to a dichotomous (Yes/No) query regarding previous Buprenorphine usage in their lifetime. The percentage of participants who responded "Yes" to prior Buprenorphine use is summarized by study arm. | Count of Participants | Participants |
|
| Opioid Use Disorder (OUD) Criteria | The mean number of OUD criteria (based on The American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, DSM-5, criteria) met per participant at baseline was summarized by study arm using basic descriptive statistics. The DSM-5 Checklist, an 11-item questionnaire measuring the number of diagnostic criteria for a substance use disorder met by an individual, has a range of 0-11 with a higher score representing more criteria met. The DSM-5 defines meeting 2-3 criteria as OUD mild, 4-5 criteria as OUD moderate, and 6 or more criteria as OUD severe. | Mean | Standard Deviation | criteria |
|
| Heroin use | The number of days of Heroin use over the prior 30-day period was assessed based on participant responses to a survey administered at baseline. Group mean values are summarized by study arm using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| Methadone Use | The number of days of Methadone use over the prior 30-day period was assessed based on participant responses to a survey administered at baseline. Group mean values are summarized by study arm using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| Opioid or Analgesic Use | The number of days of Opioid or Analgesic use over the prior 30-day period was assessed based on participant responses to a survey administered at baseline. Group mean values are summarized by study arm using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| Alcohol Use | The number of days of Alcohol use over the prior 30-day period was assessed based on participant responses to a survey administered at baseline. Group mean values are summarized by study arm using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| Cocaine Use | The number of days of Cocaine use over the prior 30-day period was assessed based on participant responses to a survey administered at baseline. Group mean values are summarized by study arm using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| Amphetamine Use | The number of days of Amphetamine use over the prior 30-day period was assessed based on participant responses to a survey administered at baseline. Group mean values are summarized by study arm using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| Polysubstance Use | The number of days of polysubstance use (i.e., 2 or more drugs taken together) over the prior 30-day period was assessed based on participant responses to a survey administered at baseline. Group mean values are summarized by study arm using basic descriptive statistics. | Mean | Standard Deviation | days |
|
| OG001 | Enhanced Referral | In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment Buprenorphine: all participants will receive buprenorphine |
|
|
|
| Secondary | Treatment Retention | Treatment retention was assessed by the number/percentage of participants who had a medical visit AND active buprenorphine prescription each month after buprenorphine initiation for 6 months. Results are summarized by study arm. | Posted | Count of Participants | Participants | 6 months |
|
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|
|
| Secondary | HIV Risk Behaviors | Change in HIV risk behaviors will be assessed using the HIV risk behavior survey. This survey, consisting of a dichotomous (yes/no) measure of injection risk, will be used based on self-report of at least one risk behavior (sharing syringes, not using bleach to clean syringes, sharing cookers, or front/back loading of syringes) reported during the interval. The number of participants demonstrating at least one risk behavior is during the 6 month interval is summarized by study arm. | HIV Risk behavior data was unable to be collected from 12 participants in the onsite buprenorphine treatment (O-BMT) study arm and 9 participants in the Enhanced referral study arm. Accordingly, there is no HIV risk behavior data to report for these participants. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Buprenorphine Diversion | Buprenorphine diversion will be defined as having at least one problem behavior: non-adherence to prescribed medication on electronic monitoring, self-reported diversion, or a urine sample consistent with diversion during the 6 month interval. This outcome measure is used to determine how many participants sell or give away prescribed medication. The number of participants with at least one problem behavior is summarized by study arm. | Posted | Count of Participants | Participants | 6 months |
|
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|
|
| Secondary | Incremental Cost-effectiveness Ratio (ICER) | The ICER will be calculated by dividing the incremental mean cost of the O-BMT arm relative to the control arm by the incremental mean effectiveness of the O-BMT arm relative to the control arm. The primary economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. ICER is a composite measure that incorporates QALYs (also reported as a separate outcome measure) and mean costs (also reported as a separate outcome measure). | Posted | Number | Ratio (US dollars/QALY) | 6 months |
|
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|
|
| Secondary | Quality-adjusted Life-years (QALYs) Gained | The main economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. Mean years gained are summarized by study arm. | Posted | Mean | 95% Confidence Interval | years gained | 6 months |
|
|
|
|
| Secondary | Mean Difference in Total Costs | Mean cost (in US dollars) of the O-BMT arm were compared to the control arm. The resource utilization and resulting cost of implementing and administering the O-BMT intervention were estimated using microcosting analysis and participant self-report. Mean costs (in US dollars) are summarized by study arm. | Posted | Least Squares Mean | 95% Confidence Interval | US Dollars | 6 months |
|
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|
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| Secondary | Time to First Buprenorphine Prescription | Time to first buprenorphine prescription is defined as the amount of time, in days, from when a participant enrolled in the study to receipt of first buprenorphine prescription. Results are summarized by study arm using basic descriptive statistics. | Time to first buprenorphine prescription results data was only available, and reported, from the sub-group of participants that received a prescription. | Posted | Mean | Standard Deviation | days | 1 month |
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| Secondary | Number/Percentage of Participants Who Received Any Buprenorphine Prescription | The Number/percentage of participants who received any buprenorphine prescription is defined as the number/percentage of participants that filled at least one prescription for buprenorphine while enrolled in the study. Results are summarized by study arm. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Total Time Prescribed Buprenorphine | Total time prescribed buprenorphine is defined as the amount of time in days that participants were prescribed buprenorphine during the study period. Results are summarized by study arm using basic descriptive statistics. | Total time prescribed buprenorphine results data was only available, and reported, from the sub-group of participants that received a prescription. | Posted | Mean | Standard Deviation | days | 6 months |
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| Post-Hoc | Buprenorphine Adherence (Self-reported) | Buprenorphine Adherence (self-reported), defined as meeting the primary outcome of buprenorphine engagement and self-reporting buprenorphine use at 30 days, was assessed as a composite measure for sensitivity analysis. The number of participants who both maintained an active buprenorphine prescription at 30 days after randomization, based on a dichotomous (i.e., Yes/No) measure, AND self-reported having taken buprenorphine on 1 or more days during the 30-day period were tabulated. Data are summarized by study arm. | Self-reported buprenorphine use data was unable to be collected from 20 participants in the onsite buprenorphine treatment (O-BMT) study arm and 15 participants in the Enhanced referral study arm. | Posted | Count of Participants | Participants | 30 days after randomization |
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| Post-Hoc | Buprenorphine Adherence (Confirmed) | Buprenorphine Adherence (confirmed) was defined as meeting the primary outcome and having a urine drug screen positive for buprenorphine at 30 days. This outcome was assessed as a composite measure for sensitivity analysis. The number of participants who both maintained an active buprenorphine prescription at 30 days after randomization, based on a dichotomous (i.e., Yes/No) measure, AND tested positive for Buprenorphine in their urine sample following the 30-day period were tabulated. Data are summarized by study arm. | Urine samples were unable to be collected from 26 participants in the onsite buprenorphine treatment (O-BMT) study arm and 23 participants in the Enhanced Referral study arm. As such, an assessment was unable to be made for these participants. | Posted | Count of Participants | Participants | 30 days after randomization |
|
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 2 |
| 48 |
| EG001 | Enhanced Referral | In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment Enhanced referral: Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment Buprenorphine: all participants will receive buprenorphine | 0 | 49 | 2 | 49 | 1 | 49 |
|
| Skin Infection (Abscess) | Infections and infestations | Non-systematic Assessment | Verbatim Term: Abscess - arm. Secondary to blood clot. Hospitalized for 3 days |
|
| Skin Infection (Methicillin-resistant Staphylococcus aureus) | Infections and infestations | Non-systematic Assessment | Verbatim term: Methicillin-resistant Staphylococcus aureus Infection. Hospitalized for 7 days |
|
| Transportation Accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Endometriosis pain | Infections and infestations | Non-systematic Assessment |
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |