anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria for Bipolar Disorder

currently or most recently in a Manic Episode (Single Manic Episode or Most Recent Episode Manic) or
currently or most recently in a Hypomanic Episode or
currently or most recently in a Mixed Episode or
currently or most recently in a Major Depressive Episode
and confirmed by the module D of the SCID (Semi-Structured Interview).
Patients must be more than 18 of age at Visit 0.

Exclusion Criteria:

A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at the investigator's opinion, with the evaluation.
Patients on antidepressant or mood stabilizer therapy one week (four weeks with fluoxetine) prior to Visit 1, with the exception of mood stabilizer therapy considered in the opinion of the investigator as an efficient treatment for at least one year prior to the study.
Intervention: Eletriptan
Trial phase: Phase 4
ATC code: N02CC06
SMILES: CN1CCC[C@@H]1Cc1c[nH]c2ccc(CCS(=O)(=O)c3ccccc3)cc12
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 71
Group description: Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
Eligibility criteria:
Inclusion Criteria:

age 18-45 healthy menstruating female

Exclusion Criteria:

cardiac or other conditions precluding use of eletriptan
Intervention: Atomoxetine
Trial phase: Phase 2 | Phase 3
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Atomoxetine
Eligibility criteria:
Inclusion Criteria:

Men and Women, ages 18-65, in good general health
Meet DSM-IV criteria for Social Anxiety Disorder

Exclusion Criteria:

Pregnant or breastfeeding
Narrow angle glaucoma
Any uncontrolled medical condition or any medical condition which would represent a contraindication to atomoxetine (Strattera) pharmacotherapy (e.g., hepatic insufficiency, untreated hypertension, untreated cardiovascular or cerebrovascular disease)
Any concomitant non-psychotropic medications that the physician determines are a contraindication to atomoxetine (Strattera) pharmacotherapy (e.g., Albuterol, various pressor agents)
Bipolar disorder, or any psychotic or organic mental disorder or dementia
Current substance abuse or dependency
Current active suicidal ideation
Current use of herbal psychoactive treatments such as St. John's Wort
Concurrent psychotropic medication is not permitted for 2 weeks prior to randomization (4 weeks in the case of fluoxetine) or at any point thereafter.
Receipt of formal psychotherapy concurrently
Inability, in the investigator's opinion, to comply with study procedures or assessments
Intervention: Vorinostat
Trial phase: Phase 2
ATC code: L01XH01
SMILES: O=C(CCCCCCC(=O)Nc1ccccc1)NO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).

Only vortinostat group adverse events were reported or collected to assess association of events with the agent in question.
Eligibility criteria:
Inclusion Criteria:

No prior or concurrent hormonal therapy for breast cancer
Histologically confirmed breast cancer, stage I-III disease, scheduled to undergo definitive surgery or other primary treatment (e.g., preoperative/neoadjuvant systemic treatment) for breast cancer
ECOG 0-2 OR Karnofsky 60-100%
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Bilirubin normal
AST and ALT ≤ 2.5 times upper limit of normal
PT ≤ 14 seconds
Creatinine normal
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No ongoing or active infection
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled intercurrent illness
No history of allergic reaction attributed to compounds of similar chemical or biologic composition to vorinostat
At least 30 days since prior hormone replacement therapy (e.g., estrogen and/or progestin)
Concurrent vaginal hormone preparations (e.g., vagifem or estring) allowed
No concurrent birth control pills
No prior radiotherapy to the ipsilateral breast
No prior or concurrent radiotherapy for breast cancer
No prior or concurrent novel therapy for breast cancer
At least 14 days since prior valproic acid or another histone deacetylase inhibitor
No other concurrent investigational agents
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent therapy for this cancer
WBC ≥ 3,000/mm^3

Exclusion criteria:

Patients must not be recieving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to SAHA.
Patients may not be taking valproic acid or another histone deacetylase inhibitor for at least 2 weeks prior to initiating SAHA.
Women who are pregnant.
Intervention: Gefitinib
Trial phase: Phase 2
ATC code: L01EB01 | L01XE02
SMILES: COc1cc2ncnc(Nc3ccc(F)c(Cl)c3)c2cc1OCCCN1CCOCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Gefitinib
Eligibility criteria:
Inclusion Criteria:

Advanced Non Small cell Lung Cell Lung cancer
Never received chemotherapy
Up and about 50% of waking hours

Exclusion Criteria:

Spread of lung cancer to the brain
Low level of white blood cells
Radiotherapy within 4 weeks

Patients were entered to this study, initiated in 2004, before the significance of predictive factors such as smoking history, adenocarcinoma histology and mutation status was described.
Intervention: Humulin N
Trial phase: Not Applicable
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: High RAS activity is described in the protocol
Eligibility criteria:
Inclusion Criteria:Male Age 18-40 years Right-handed In good general health based on history High/low RAS activity (high ACE activity, A-allele for angiotensin II receptor (subtype 2) and high plasma angiotensinogen, or low ACE activity, low plasma angiotensinogen and not carrier of the A-allele for angiotensin II receptor (subtype 2)).

-

Exclusion Criteria:

Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year

-
Intervention: Humulin N
Trial phase: Not Applicable
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Low RAS activity is described in the protocol
Eligibility criteria:
Inclusion Criteria:Male Age 18-40 years Right-handed In good general health based on history High/low RAS activity (high ACE activity, A-allele for angiotensin II receptor (subtype 2) and high plasma angiotensinogen, or low ACE activity, low plasma angiotensinogen and not carrier of the A-allele for angiotensin II receptor (subtype 2)).

-

Exclusion Criteria:

Any evidence of mental, neurological or medical illnesses. The presence of ferromagnetic metal in the body. Claustrophobia Exposure to radiation within the last year

-
Intervention: Methylphenidate
Trial phase: Phase 3
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual for Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for ADHD
Meet DSM-IV diagnostic criteria for at least one non-nicotine substance use disorder
Has a DSM-IV ADHD Symptom Checklist score ≥ 22 derived from the adolescent-completed checklist

Exclusion Criteria:

Serious medical illness
History of tic disorder
Pregnant or breastfeeding
Meet DSM-IV criteria for current or life-time psychotic disorder
Meet DSM-IV criteria for current or life-time bipolar disorder
Requires/or prescribed other concurrent psychotropic medication
Taking any medications that may produce interactions with OROS-MPH
Opiate dependence
Methamphetamine abuse or dependence
Suicidal risk
Enrolled in an inpatient, residential, day treatment, or outpatient substance abuse program within 28 days prior to signing consent
Intervention: Edaravone
Trial phase: Phase 4
ATC code: N07XX14
SMILES: CC1=NN(c2ccccc2)C(=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Edaravone Group

edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy
Eligibility criteria:
Inclusion Criteria:

Initial AMI patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention.

Exclusion Criteria:

Renal insufficiency defined as serum creatinine > 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase > 50 IU/L, alanine aminotransferase > 50 IU/L and total bilirubin > 1.2 mg/dl.
Intervention: Ruboxistaurin
Trial phase: Phase 3
SMILES: CN(C)C[C@@H]1CCn2cc(c3ccccc32)C2=C(C(=O)NC2=O)c2cn(c3ccccc23)CCO1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 203
Group description: 32 mg given once daily as oral tablet for 2 years.
Eligibility criteria:
Inclusion Criteria:

Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment.

Exclusion Criteria:

Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.
Intervention: ALENDRONIC ACID
Trial phase: Phase 1 | Phase 2
ATC code: M05BA04 | M05BB03 | M05BB05 | M05BB06
SMILES: NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: subjects received Risedronate for one year

Risedronate 35 Mg: risedronate 35 mg weekly
Eligibility criteria:
Inclusion Criteria:

Adults with end stage renal disease who are undergoing living donor kidney transplantation
Intervention: Testosterone
Trial phase: Phase 2 | Phase 3
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 18
Group description: A prospective, open-label, controlled drug intervention trial was performed in healthy hypogonadal and eugonadal outpatient men with chronic spinal cord injury (Treatment: serum testosterone concentration <4.0 mg/dL and Control: serum testosterone concentration ≥4.0 mg/dL). Treatment subjects received a transdermal testosterone patch (5 or 10 mg; Androderm, Watson Pharma Inc.) daily for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. Only outcome measures were assessed for the no intervention arm; no adverse events were collected.
Eligibility criteria:
Inclusion Criteria:

Males 18-49 years of age
Chronic spinal cord injury
Normal prostate specific antigen levels and digital rectal exam
No known cardiovascular disease
Subjects with total testosterone > 4 ng/ml
Subjects with total testosterone > 4 ng/ml

Exclusion Criteria:

Females
Known coronary heart and/or artery disease, diabetes mellitus
Previous or current cancer
Current or previous anabolic steroid use
Acute inter-current illness
Abnormal liver function test (>1.5 times normal values) at baseline
Prostate specific antigen above normal
Abnormal digital rectal exam at baseline suggestive of malignancy
Current alcohol or drug abuse
Significant psychological disorders
Intervention: Tetracaine
Trial phase: Phase 2
ATC code: C05AD02 | D04AB06 | N01BA03 | N01BA53 | S01HA03
SMILES: CCCCNc1ccc(C(=O)OCCN(C)C)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: 1 g of topical amethocaine gel 4%.
Eligibility criteria:
Inclusion Criteria:

Term neonates > 37 weeks and
Birth weight > 2500 grams (appropriate for gestational age - AGA) -

Exclusion Criteria:

1.Neonates with major congenital anomalies 2.Neonates with known neurological abnormalities (antenatally diagnosed) 3.Neonates who require admission to the neonatal intensive care unit at birth

-
Intervention: Pentoxifylline
Trial phase: Phase 2 | Phase 3
ATC code: C04AD03 | R03DA20
SMILES: CC(=O)CCCCn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Patients in this group received pentoxifylline 400mg tid for 1 year.
Eligibility criteria:
Inclusion Criteria:

Subjects must be willing to give written informed consent
Diagnosis of steatohepatitis Grade >= 1 (Brunt et al. criteria - Am J Gastroenterology 1999;94(9)2467-74) on biopsy within 6 months prior to entry into protocol
No histologic evidence of cirrhosis
Persistent ALT elevation (> 1.5 the upper limit normal) over 6 months prior to entry into study
Adult subjects 18-65 years of age of any race or gender

Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:

Hemoglobin > 11 gm/dL for females and > 12 gm/dL for males
White blood cell (WBC) > 2.5 K/UL
Neutrophil count > 1.5 K/UL
Platelets > 100 K/UL
Direct bilirubin, within normal limits
Indirect bilirubin within normal limits (unless non-hepatitis factors such as Gilbert's disease explain indirect bilirubin rise. In such cases total bilirubin must be < 3.0 mg/dL)
Albumin > 3.2 g/dL
Serum creatinine within normal limits
Hemoglobin A1c (HgbA1c) < 7%
Antinuclear antibodies (ANA) < 1:160
Anti-smooth muscle Ab negative
Serum hepatitis B surface antigen (HepBsAg) negative
Serum hepatitis C antibody (HepC Ab) negative
Iron/total iron binding capacity (TIBC) ratio (transferrin saturation) < 45%
Alpha-1-antitrypsin level within normal limits
Ceruloplasmin level within normal limits
Negative pregnancy test (females)
Concomitant use of lipid lowering agents at study entry will not exclude patients from the study.

Exclusion Criteria:

Evidence of decompensated cirrhosis
Active gastrointestinal (GI) bleeding
Renal failure (creatinine clearance < 80 mL/min)
Active alcohol or drug abuse
Uncontrolled diabetes (HgbA1c > 7)
Current treatment with anti-diabetic medications such as thiazolidinediones or metformin (stable doses of sulfonylureas are acceptable)
Current treatment with anti-TNF alpha medication (i.e. Remicade or Enbrel)
Current treatment with vitamin E
Alcohol consumption < 20 g/day (males) or < 10 g/day (females) - assessed by one physician and confirmed with one family member.
HIV positive status
Any history of cerebral and/or retinal hemorrhage
Prior intolerance of pentoxifylline or any other methylxanthine (i.e. caffeine, theophylline, or theobromine)
Current use of theophylline
Known diagnosis of malignancy
Any other conditions which the investigator feels would make the subject unsuitable for enrollment, or could interfere with the subject completing the protocol
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: rifaximin 400mg taken 3 times a day

Rifaximin (Xifaxan)
Eligibility criteria:
Inclusion Criteria:

Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort.
Subject has a positive Clostridium difficile stool toxin assay at screening

Exclusion Criteria:

Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months.
Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS])
Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization.
Intervention: Vancomycin
Trial phase: Phase 3
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: vancomycin 125mg taken 4 times a day
Eligibility criteria:
Inclusion Criteria:

Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort.
Subject has a positive Clostridium difficile stool toxin assay at screening

Exclusion Criteria:

Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months.
Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS])
Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization.
Intervention: Naltrexone
Trial phase: Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Active medication recipients (Naltrexone taken for 4 days).
Eligibility criteria:
Inclusion Criteria:

Participants must be greater than or equal to 18 years

Based on the medical history, physical and laboratory examination, female subjects must:

Agree in consent to practice effective contraception during study, be status post-bilateral tubal litigation or be post-menopausal.
Not be pregnant, nursing, or planning pregnancy
Based upon self-report, subjects must smoke greater than or equal to 10 non-menthol cigarettes per day
Because the OPRM1 variant is common (25-30%) in persons of European ancestry, but very rare in other ethnic groups (e.g., 2-9% of African Americans) it is not scientifically justified to include members of other ethnic groups. Therefore, only persons of European ancestry will be recruited.
Following orientation by the research staff, subjects must sign written informed consent and HIPAA form.

Exclusion Criteria:

Current diagnosis of kidney disease or history of renal function impairment (unless they have recent kidney function tests (within last 3 months) and approval of their primary physician to participate in the study.)
Women who are pregnant, planning a pregnancy, or lactating
Current alcohol use > 25 standard drinks/week (this is because NTX is used to treat alcohol dependence, and effects of NTX on alcohol consumption in alcohol dependent subjects could have indirect effects on cigarette consumption).
Current medical problems for which NTX is contraindicated including: active hepatitis (Liver Function Tests 3 times the Upper Limit of Normal).
History of opiate dependence (prescription drug or illicit use).
History of or current Diagnostic and Statistical Manual of Mental Disorders (Version IV) (DSM IV) substance use disorders (abuse or dependence involving alcohol, cocaine, stimulants, or benzodiazepines)
Diagnosis of bulimia and/or anorexia nervosa in the last year
Current or past use (with in past 12 months) of any medications containing NTX (e.g., Revia, Trexan), allergy to NTX
Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics)