StudyFinder
Search Results Within Category "Addiction and Substance Abuse"
3 Study Matches
Comprehensive Tobacco Cessation for Cancer Patients and Survivors
Antonice Wall - walla2@vcu.edu
NCT05805722
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with study procedures and availability for the duration of the study
* Have a documented history of cancer of any type, whether active or in remission
* Identify as a current or recently-quit tobacco user
Exclusion Criteria:
* Not a VCUHealth patient
* Non English-speaking BEHAVIORAL: Behavioral counseling for tobacco cessation
Tobacco Use Cessation, Cancer
Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion
Tiffany Pignatello - Tfitz@vcu.edu
NCT05976646
Inclusion Criteria:
* Males and female subjects between 18 - 65 years of age;
* Understand the study procedures and provide written informed consent in the English language.
* Meet current DSM-5 criteria for OUD, of at least moderate severity, currently engaged in MOUD treatment at a buprenorphine-naloxone sublingual film total daily dose ranging from 8mg/2mg to 24mg/6mg or buprenorphine sublingual tablet 5.7mg/1.4mg to 17.1/4.3 daily for at least 2 weeks at screening. Or on a stable dose of depot injectable buprenorphine for at least four months, with at least one week since last depot buprenorphine injection.
* Have a positive urine drug screen for buprenorphine during screening and upon presenting for the first laboratory day on the clinical research unit to document buprenorphine use;
* Quick Inventory of Depressive Symptomatology (16-Item) (QIDS-SR16) score of mild or greater (\>6)
* Females must be non-pregnant and non-lactating. Additionally, for females with childbearing potential (ie., have not undergone sterilization via hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or at least 1 year post-menopausal), participants must agree to use an acceptable form of contraception during study participation and to continue its use for at least 30 days after the last dose of the study drug (e.g, abstinence, intrauterine device, hormonal implant, hormonal patch/ring/pill, condoms (male or female).
Exclusion Criteria:
* Contraindications for participation as determined by medical history and physical exam performed by study NP or study physician;
* Pregnant or nursing women;
* Baseline ECG with clinically significant abnormal conduction;
* Uncontrolled serious psychiatric or major medical disorder; including uncontrolled hypertension, seizure disorder, anorexia nervosa or bulimia, bipolar disorder, schizoaffective disorder, or schizophrenia;
* Taking antidepressant medications (tricyclic antidepressants, SSRIs, SNRIs, MAOIs), antibiotic linezolid, antiepileptics, or CNS stimulants (amphetamine, methylphenidate) within the two weeks prior to initiation of study medication
* History of adverse reaction or allergy to dextromethorphan or bupropion
* Current severe alcohol use disorder or current benzodiazepine use or recent (within last 3 months) discontinuation of alcohol with severe alcohol use disorder or discontinuation of benzodiazepines with severe benzodiazepine use disorder
* Current DSM-5 diagnosis of any psychoactive substance use disorder other than opioids, cocaine, marijuana, or nicotine, or mild or moderate alcohol use disorder. Diagnosis of mild to moderate use disorder for alcohol will not be considered exclusionary.
* Significant current suicidal or homicidal ideation (C-SSRS "yes" answers on questions 4 or 5) or a history of suicide attempt within the past 6 months.
* Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. DRUG: Placebo, DRUG: Auvelity
Addiction, Opioid Use, Substance Use Disorders, Opioid Use Disorder
Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
Tiffany Pignatello, FNP - study4u@vcu.edu
NCT05886582
Inclusion Criteria:
* Male or female subjects between 25 and 70 years of age.
* Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe
* Able to understand and comply with study procedures
* Have positive urine result for cocaine metabolite benzoylecgonine (BE) during at least one screening visit (out of up to three visits, depending on participants' preference) AND/OR self-report of recent cocaine use (approximately past 30 days).
* Have hematology and chemistry laboratory tests that are within normal limits, except that liver function tests must be no more than 2x of the upper limit of normal (if any elevation is above the limit - must be judged by the study physician to be clinically insignificant).
* No clinically significant abnormalities on baseline ECG.
* Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory and fMRI testing.
* Women must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device with spermicide, or condoms). Men will be advised to use condoms. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation.
* Body Mass Index (BMI) between 18-45kg/M2 and weight of at least 50kg at screening
Exclusion Criteria:
* Have concurrent secondary DSM-5 diagnosis of any psychoactive substance use disorder other than cocaine, alcohol, methamphetamine, nicotine, opioid, or marijuana use disorder.
* Have a DSM-5 axis I psychiatric disorder other than substance use disorder, including but not limited to Bipolar I Disorder, Schizophrenia, or other psychotic disorder that require treatment with antipsychotics, or a neurological disorder requiring ongoing treatment and/or making study participation unsafe. Comorbid PTSD, Generalized Anxiety Disorder and Major Depressive Disorder will be allowed.
* Consistent and regular (as opposed to intermittent, infrequent, or as needed) use of medications contraindicated for concurrent use along with RTG, or would confound the mechanism of RTG action and data interpretation. These include DA antagonists such as antipsychotic medications (especially neuroleptics) or metoclopramide.
* Subjects with evidence or history of any clinically significant medical disorder including biliary obstruction, clinically significant hepatic disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, or endocrine disease. However, controlled hypertension, controlled hypothyroidism, and cancer in remission over 5 years will not be excluded.
* Have a history of seizures (excluding childhood febrile seizures) or loss of consciousness (e.g. from traumatic brain injury) for more than 30 minutes.
* Have significant current suicidal or homicidal ideation or a suicide attempt within the past 6 months, based on the Columbia Suicide Severity Rating Scale (C-SSRS).
* Be HIV positive by self-report or history.
* Be pregnant or nursing or not using a reliable form of contraception if able to conceive. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation
* Have any other illness, or condition, which in the opinion of the clinical co-investigator (Arias) would preclude safe and/or successful completion of the study.
* Be allergic to rotigotine.
* Have taken any investigational drug within 45 days prior to baseline
* Demonstrate intolerance to, poor adherence to, or extreme skin irritation by daily application of known placebo "practice" skin patches during the screening phase
* Current/pending criminal charges that may result in incarceration within the next 60 days
* Self-report of allergic or other reactions to sulfites (e.g. in foods) DRUG: Rotigotine Transdermal System [Neupro], DRUG: Placebo
Substance-Related Disorders