Clinical trials: Substance Addiction
Opioid Related Disorders, Opiate Addiction
Monitoring Patterns of Prescribing to Identify Changes in Access to ER/LA Opioid Analgesics
Changes in prescribing will be compared in prescribers from specialties whose prescribing is hypothesized to be relatively unaffected by the REMS (such as oncologists and hospice providers) versus those for whom the REMS could…
- Conditions
- Opioid Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02920775
- Testing
- Non-interventional study - retrospective database review
- Volunteers
- 360,000 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid-use Disorder, Opioid-related Disorders
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine…
- Trial name
- RECOVER® (NCT03604861)
- Testing
- Not applicable - no defined intervention
- Where
- 35 sites in United States
- Volunteers
- 534 people
- Sponsor
- Indivior Inc.
Smoking Cessation, Nicotine Addiction
Innovative Digital Therapeutic for Smoking Cessation
This study is comparing the efficacy of two smoking cessation apps.
- Conditions
- Smoking Cessation, Nicotine Addiction, Drug Addiction, Drug Dependence
- Trial name
- NCT03694327
- Testing
- CT-101-M, QuitGuide
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- My Digital Study
Addiction, Addiction, Alcohol
The Efficacy of a Mobile Application in Reducing Craving and Lapse Risk in Alcohol and Stimulants Problematic Use
The aim of the study is to evaluate the effectiveness of long-term and short-term app-based self-guided psychological interventions to reduce craving and lapse risk in users with substance use disorder or problematic substance…
- Conditions
- Addiction, Addiction, Alcohol, Addiction, Substance
- Trial name
- NCT05434416
- Testing
- mobile app
- Where
- Poland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PredictWatch
Substance Use Disorders, Addiction, Alcohol
Evaluating the Effectiveness of Mobile Self-guided Psychological Interventions to Reduce Relapse in Substance Use Disorder
The aim of the study is to evaluate the effectiveness of mobile interventions in reducing craving and lapses in patients diagnosed with Substance Use Disorder.
- Conditions
- Substance Use Disorders, Addiction, Alcohol, Addiction, Substance
- Trial name
- NCT05730504
- Testing
- Mobile app-based self-guided interventions
- Where
- Poland
- Volunteers
- 400 people
- Sponsor
- PredictWatch
Opioid Use Disorder
A Stepped-Wedge Cluster Randomized Trial of a Digital App to Support Medication-Assisted Treatment in Individuals With Opioid Use Disorder
The goal of this clinical trial is to learn if a mobile health app called Recovery Connect can help people stay in treatment for opioid use disorder.
- Trial name
- SMART-OUD (NCT07140926)
- Testing
- Recovery Connect
- Where
- 9 sites in United States
- Volunteers
- 1,524 people
- Sponsor
- Bright Therapeutics
Substance Withdrawal Syndrome, Opiate Addiction
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction
The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.
- Conditions
- Substance Withdrawal Syndrome, Opiate Addiction, Opiate Dependence
- Trial name
- NCT02801357
- Testing
- lofexidine administration in subjects seeking buprenorphine dose reduction
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opiate Dependence, Drug Dependence
A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)
The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto…
- Conditions
- Opiate Dependence, Drug Dependence, Substance Dependence
- Trial name
- NCT00604188
- Testing
- Suboxone (SCH 000484), Subutex (SCH 028444)
- Volunteers
- 188 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Surveillance for Emergency Department Visits and Hospitalizations for Overdose and Poisoning
Study to evaluate the impact of the ER/LA opioid REMS program on the incidence of Emergency Department visits and hospitalizations for overdose/poisoning and death among patients prescribed ER/LA opioid analgesics.
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02866266
- Testing
- Retrospective database review
- Volunteers
- 183,452 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opioid Addiction
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid Addiction
The purpose of this study is to verify efficacy and safety of a bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a treatment option for severe opioid addiction.
- Trial name
- NCT02282072
- Testing
- Deep brain stimulation：PINS Stimulation System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Beijing Pins Medical Co., Ltd
Heroin Addiction
Observational Study to Assess the Efficacy and Tolerability of Eptadone®, in Heroin Addicted Patients in a MMT
The efficacy and tolerability of Eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.
- Trial name
- METHODE (NCT02062723)
- Where
- 22 sites in Germany
- Volunteers
- 515 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Substance Dependence
A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before.
- Trial name
- NCT00728897
- Testing
- GSK598809 new formulation, GSK598809 old formulation
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pain, Pain, Acute
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
This study will test the quality of opioid-related physician care decisions using a patient-simulation based measurement and feedback approach that combines multiple-choice care decisions with real-time, personalized scoring and…
- Conditions
- Pain, Pain, Acute, Pain, Chronic, Pain, Neuropathic
- Trial name
- NCT04080037
- Testing
- Quality IQ Patient Simulations
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Qure Healthcare, LLC
Opiate Addiction, Medication Non-adherence
Using Artificial Intelligence To Monitor Medication Adherence in Opioid Replacement Therapy
This study uses an artificial intelligence platform to automatically confirm medication ingestion. The Health Insurance Portability and Accountability Act (HIPAA)-compliant platform can be downloaded as an 'app' onto any…
- Conditions
- Opiate Addiction, Medication Non-adherence, Addiction, Opioid Dependence
- Trial name
- NCT02243670
- Testing
- AiCure monitoring and intervention
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- AiCure
Alcohol Use Disorder, Alcoholism
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment.
- Conditions
- Alcohol Use Disorder, Alcoholism, Alcohol Abuse, Alcohol Dependence
- Trial name
- NCT07216872
- Testing
- Deep TMS (DTMS)
- Where
- 11 sites in United States, Israel and 1 more
- Volunteers
- 186 people
- Sponsor
- Brainsway
Cocaine-related Disorder
Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)
This study assessed whether AFQ056 had a beneficial effect by reducing cocaine use in Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.
- Trial name
- NCT03242928
- Testing
- AFQ056
- Where
- 8 sites in Argentina, Spain and 1 more
- Volunteers
- 68 people
- Sponsor
- Novartis Pharmaceuticals
Opioid Dependence
Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
Buprenorphine (BPN) is an approved treatment for opioid dependence, however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low.
- Trial name
- NCT00447564
- Testing
- Probuphine
- Where
- 18 sites in United States
- Volunteers
- 163 people
- Sponsor
- Titan Pharmaceuticals
Opioid-related Disorders, Opioid Addiction
ER/LA Opioid Analgesics - Surveillance Monitoring of State Medical Examiner Databases
In April 2011, the U.S. Food and Drug Administration (FDA) determined that a class-wide risk evaluation and mitigation strategy (REMS) for all extended-release (ER) and long-acting (LA) opioid medications was necessary to support…
- Conditions
- Opioid-related Disorders, Opioid Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- NCT02897414
- Testing
- Surveillance of state medical examiner databases
- Volunteers
- 13,015 people
- Sponsor
- ER/LA Opioid REMS Program Companies (RPC)
Opiate Dependence
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid…
- Trial name
- NCT00678418
- Testing
- VIVITROL® 380 mg
- Where
- Russia
- Volunteers
- 250 people
- Sponsor
- Alkermes, Inc.
Alcohol Dependence
ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.
- Trial name
- NCT00501631
- Testing
- VIVITROL 380 mg
- Volunteers
- 300 people
- Sponsor
- Alkermes, Inc.