Clinical trials: Substance-Related Disorder
Substance Dependence, Alcohol Dependence
Effects of GSK598809 on Brain Activation in Abstinent Alcoholics
This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers. A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like the real drug.
- Trial name
- NCT00908206
- Testing
- GSK598809
- Sponsor
- GlaxoSmithKline
Opiate-related Disorders, Opiate Dependence
Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)
This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®.
- Conditions
- Opiate-related Disorders, Opiate Dependence, Drug Abuse
- Trial name
- NCT00684073
- Testing
- buprenorphine, buprenorphine/naloxone
- Volunteers
- 60 people
- Sponsor
- Indivior Inc.
Healthy, Opioid-induced Constipation
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
- Trial name
- NCT01040637
- Testing
- TD-1211
- Where
- 3 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Glycyx Therapeutics
Substance Dependence
A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward
GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders.
- Trial name
- NCT00605241
- Testing
- GSK598809
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tobacco Dependence
Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.
Comparative pharmacokinetic study of new oral nicotine replacement therapy products.
- Trial name
- NCT01227720
- Testing
- Experimental Nicotine Replacement Therapy (NRT) 2 mg, Experimental Nicotine Replacement Therapy (NRT), Marketed Nicotine Lozenge
- Where
- 2 sites in Sweden
- Volunteers
- 104 people
- Sponsor
- McNeil AB
Opioid Use Disorder
AvertD Post-Approval Study
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
- Trial name
- NCT07135323
- Testing
- Opioid Used Disorder Risk Assessment
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Prescient Medicine Holdings, Inc.
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Neurostimulation to Improve NOWS Outcomes
The objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
- Trial name
- SPROUT (NCT05129020)
- Testing
- Sparrow Fledging Therapy System
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Spark Biomedical, Inc.
Opioid Use Disorder
Remotely Observed Methadone Evaluation II
Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs).
- Trial name
- ROME II (NCT06338280)
- Testing
- Sonara
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sonara Health
Opioid Use Disorder
Remotely Observed Methadone Evaluation
Opioid addiction, which affects 16 million individuals worldwide, can be treated using methadone, a proven and effective opioid medication for treating OUD that extends retention in care, reduces mortality, and inhibits illicit…
- Trial name
- ROME (NCT06200740)
- Testing
- Sonara
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Sonara Health
Substance Use Disorder (SUD), Mental Health Disorder
Reentry Assist (R-Assist)
This project will aim to develop and pilot test, R-Assist, a mobile health application to support individuals with co-occurring substance use and mental health disorders (COD) in their recovery, who have recently released from a…
- Conditions
- Substance Use Disorder (SUD), Mental Health Disorder, Criminal Recidivism
- Trial name
- R-Assist (NCT06980233)
- Testing
- reentry assistance mobile health app
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Meaningful Measurement, Inc
Opioid-use Disorder
SUBLOCADE Rapid Initiation Study
This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment following a shorter period of transmucosal (TM) buprenorphine treatment.
- Trial name
- NCT03993392
- Testing
- TM buprenorphine, SUBLOCADE
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Indivior Inc.
Opiate Dependency Relapse
Using mHealth to Aid Opioid Addicts
The purpose of the proposed study is perform focus groups to identify and prioritize features of the SubAID application (APP). The SubAID APP is smartphone APP being created to support patients self-managing…
- Trial name
- NCT01955902
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Care Team Solutions
Nicotine Dependence, Nicotine Dependence, Cigarettes
Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers
A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- NCT03593239
- Testing
- Tobacco flavored JUUL 1.7% ENDS, Tobacco flavored JUUL 5% ENDS, Mint flavored JUUL 1.7% ENDS
- Where
- New Zealand
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
Pain, Pain Syndrome
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Central Neuropathy of Any Genesis
Over the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates…
- Conditions
- Pain, Pain Syndrome, Pain, Chronic, Chronic Pain
- Trial name
- NCT06072001
- Testing
- Adezunap (AP707)
- Where
- Germany
- Volunteers
- 558 people
- Sponsor
- Apurano Pharmaceuticals GmbH
Opioid-use Disorder
mHealth for Patient Self-Management of Opioid Use Disorder
Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.
- Trial name
- NCT03633929
- Testing
- KIOS OUD
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Biomedical Development Corporation
Non-cancer Pain, Opioid Induced Constipation
Prucalopride Effects on Subjects With Chronic Non-cancer Pain Suffering From Opioid Induced Constipation
The study will evaluate the efficacy, safety and tolerability of prucalopride over 12 weeks of treatment in subjects aged 18 years and older with chronic non-cancer pain, suffering from opioid induced constipation.
- Trial name
- OIC (NCT01117051)
- Testing
- prucalopride
- Where
- Belgium
- Volunteers
- 174 people
- Sponsor
- Shire
Tobacco Use Disorder
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 4 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 4mg) in healthy smokers under fasting…
- Trial name
- NCT03543137
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Alcohol Dependence
ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in…
- Trial name
- NCT01218971
- Testing
- Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg
- Volunteers
- 332 people
- Sponsor
- Alkermes, Inc.
Hepatitis C, Chronic, Substance Abuse, Intravenous
Post-marketing Surveillance Study of Ex-intravenous Drug Abusers With Chronic Hepatitis C Treated With PegIntron Plus Rebetol (P04408/MK-4031-261)
Previous intravenous drug abusers with chronic hepatitis C who are under substitution therapy (buprenorphine, methadone) will be treated with PegIntron and Rebetol according to the approved European labeling.
- Trial name
- SUPPORT (NCT00726557)
- Testing
- PegIntron (pegylated interferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 246 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid Use Disorder
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use Disorder
The purpose of this study is to measure safety and efficacy and to determine dose-response relationship for INDV-2000 in participants with moderate to severe Opioid Use Disorder (OUD) who are new to treatment, have recently…
- Trial name
- NCT06384157
- Testing
- INDV-2000
- Where
- 35 sites in United States
- Volunteers
- 300 people
- Sponsor
- Indivior Inc.