Clinical trials: Substance Dependence
Opiate Dependence
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
- Trial name
- NCT00834080
- Testing
- Medisorb naltrexone 380 mg
- Where
- 11 sites in United States
- Volunteers
- 38 people
- Sponsor
- Alkermes, Inc.
Opioid Dependence
The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects
A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. Study duration is up to five days and includes a maximum of 3 days confinement in the clinic.
- Trial name
- NCT02516436
- Testing
- BEMA Buprenorphine NX, Buprenorphine
- Where
- 3 sites in United States
- Sponsor
- BioDelivery Sciences International
Tobacco Dependence
Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment
To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit
- Trial name
- NCT00749463
- Testing
- Nicotine Gum, Nicotine Patch
- Where
- 6 sites in China
- Volunteers
- 300 people
- Sponsor
- McNeil AB
Opioid Dependence
Evaluation of BEMA® Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects
This is a randomized, double blind, placebo controlled study in opioid dependent subjects. Subjects meeting entry criteria will be treated with multiple doses of B-BNX or B-Placebo, with non-responders rescued within 6 hours.
- Trial name
- NCT01713803
- Testing
- Buprenorphine and naloxone
- Where
- United States
- Sponsor
- BioDelivery Sciences International
Smoking Cessation, Nicotine Dependence
Study Assessing Efficacy and Safety of NFL-101 on Reduction of Reinforcing Properties of Cigarettes (PRECESTO)
PRECESTO is a randomized, double-blind, cross-over trial on 34 smokers who do not want to stop smoking and get high satisfaction from smoking.
- Trial name
- PRECESTO (NCT06091826)
- Testing
- NFL-101
- Where
- France
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- NFL Biosciences SAS
Opioid Dependence, Opioid Related Disorders
Treatment Seeking Participants With Opioid Use Disorders Assessing Tolerability of Depot Injections of Buprenorphine
This is a randomized, double-blind, placebo controlled, multicenter study in male and female participants who are seeking treatment for opioid use disorder.
- Trial name
- NCT02357901
- Testing
- SUBOXONE, RBP-6000
- Where
- 38 sites in United States
- Volunteers
- 665 people
- Sponsor
- Indivior Inc.
Alcoholism, Opiate Dependence
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection.
- Trial name
- NCT00156936
- Testing
- Medisorb naltrexone 380 mg, Oral naltrexone to Medisorb naltrexone 380 mg
- Volunteers
- 108 people
- Sponsor
- Alkermes, Inc.
Attention Deficit Disorder With Hyperactivity, Amphetamine-Related Disorders
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories
This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to learn if NRP104, when injected into a vein, produces a high and any other effects like amphetamine and other stimulant drugs that are…
- Conditions
- Attention Deficit Disorder With Hyperactivity, Amphetamine-Related Disorders, Substance-Related Disorders
- Trial name
- NCT00247572
- Testing
- NRP104
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- New River Pharmaceuticals
Opioid Dependence, Methadone Withdrawal Syndrome
Pilot Study of Lofexidine and Methadone Pharmacodynamic Interaction in Methadone Maintained Patients
The primary objective of this study is to assess QTc (an interval of the heart rhythm) interaction effects between lofexidine and methadone.
- Trial name
- NCT01558934
- Testing
- Lofexidine HCl
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Opioid Use Disorder
SUBLOCADE Long-term Outcomes
This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the…
- Trial name
- NCT05860959
- Where
- 49 sites in United States, Australia and 2 more
- Volunteers
- 480 people
- Sponsor
- Indivior Inc.
Substance Dependence
A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809
GSK598809 is being developed to facilitate overcoming an addiction to nicotine and to help people stop smoking. This study will investigate if GSK598809 is safe and tolerated in people who smoke and will also look at blood levels…
- Trial name
- NCT00437840
- Testing
- GSK598809
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Opioid Dependence
A Randomized, Double-Blind, Single-Center Clinical Study on the Efficacy of Naltrexone Implant in Antagonizing Opioid Agonist Hydromorphone
This study adopted a randomized, double-blind study design to evaluate the antagonistic effect, safety and pharmacokinetics of Naltrexone (opioid receptor antagonist) implantation after Hydromorphone (opioid receptor agonist)…
- Trial name
- NCT07014644
- Testing
- 1.5g Naltrexone Implant
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Shenzhen Sciencare Medical Industries Co., Ltd.
Opioid Dependence
An Open Label Study To Assess The Safety And Tolerability Of BEMA® Buprenorphine NX In Opioid Dependent Subjects
This is an open label study in opioid dependent subjects maintained on a stabilized dose of Suboxone tablets or films. The purpose is to assess the safety and tolerability of BEMA Buprenorphine NX administered once daily for 12…
- Trial name
- NCT01666119
- Testing
- BEMA Buprenorphine NX films
- Where
- 10 sites in United States
- Volunteers
- 249 people
- Sponsor
- BioDelivery Sciences International
Substance Dependence
An Open Label Positron Emission Tomography (PET) Study of GSK618334 in Healthy Male Subjects Using 11C-PHNO as PET Ligand
The purpose of this study is to investigate the relationship between the plasma concentrations of the study drug and the amount of the study drug bound to the D3 receptors of the brain after dosing of a new compound GSK618334.
- Trial name
- NCT00814957
- Testing
- GSK618334
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Opioid-use Disorder
Improving Office Based Treatment of Opioid Use Disorder With Technology
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve…
- Trial name
- NCT03586466
- Testing
- BupreCare, Buprenorphine/naloxone, MEMS
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- MedicaSafe, Inc.
Substance Dependence
GSK618334 Repeat Dose Study
The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
- Trial name
- NCT01036061
- Testing
- GSK618334 Low Dose, GSK618334 PET subjects, GSK618334 Medium Dose
- Where
- United Kingdom
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Smoking Cessation, Smoking Behaviors
Clinical Learning Study for a Mobile Smoking Cessation Program
The purpose of this study are to obtain learnings regarding the Digital Therapeutic (DTx) experience of Clickotine, including acceptability and preference of the overall program and specific DTx components, as well as to obtain…
- Conditions
- Smoking Cessation, Smoking Behaviors, Smoking Reduction, Smoking, Cigarette
- Trial name
- NCT04857515
- Testing
- Clickotine®
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Click Therapeutics, Inc.
Opioid Dependency
Study of Probuphine in Patients With 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
- PRO-809 (NCT00772785)
- Testing
- Probuphine (buprenorphine implant)
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Titan Pharmaceuticals
Opioid Use Disorder, Opioid Withdrawal
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use…
- Conditions
- Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
- Trial name
- IBO-CARE (NCT07871877)
- Testing
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Clive Michelsen
Opioid Dependency
A Six-Month Randomized Controlled Trial (RCT) of Probuphine Safety and Efficacy in Opioid Addiction
Probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This study will confirm the efficacy of Probuphine vs.
- Trial name
- NCT01114308
- Testing
- Probuphine (buprenorphine implant), Buprenorphine
- Where
- 20 sites in United States
- Volunteers
- 287 people
- Sponsor
- Titan Pharmaceuticals