Clinical trials: Substance Dependency
Opiate Dependence
Study of Buprenorphine-Naloxone Sublingual Spray and Suboxone® Sublingual Film in Healthy Volunteers
The primary objective of this study is to compare the bioavailability of a test formulation of Buprenorphine Naloxone Sublingual (SL) spray to that of a single dose of Suboxone® (buprenorphine and naloxone) sublingual film, under…
- Trial name
- NCT02477267
- Testing
- SL spray, SL film
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- INSYS Therapeutics Inc
Alcoholism
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
- Trial name
- NCT00156923
- Testing
- Medisorb naltrexone 380 mg, Medisorb naltrexone 190 mg
- Volunteers
- 108 people
- Sponsor
- Alkermes, Inc.
Opioid Dependence, Opioid Related Disorders
A Randomized, 4-sequence, 2-period, Double-blind, Placebo Controlled Study With a DSM-IV-TR Diagnosis of Cocaine Abuse
This is a randomized, 4-sequence, 2-period, double-blind, placebo controlled study in male and female subjects with an American Psychiatric Association Diagnostic and Statistical Manual DSM-IV-TR diagnosis of cocaine abuse.
- Conditions
- Opioid Dependence, Opioid Related Disorders, Cocaine Dependence
- Trial name
- RBP-8000 (NCT01846481)
- Testing
- RBP-8000 100 mg, Cocaine, RBP-8000 200 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
Opioid Dependence
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence
This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).
- Trial name
- PRO-810 (NCT00768482)
- Testing
- Probuphine (buprenorphine implant), Sublingual Buprenorphine
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Titan Pharmaceuticals
Opioid-Related Disorders
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a…
- Trial name
- NCT00640835
- Testing
- Buprenorphine/naloxone Film Strip
- Where
- 3 sites in United States
- Volunteers
- 382 people
- Sponsor
- Indivior Inc.
Addiction, Behavioral Addiction
Mobile Health for Problematic Behaviors and Substance 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 problematic behaviors (compulsive sex, pornography…
- Conditions
- Addiction, Behavioral Addiction, Nicotine Addiction, Nicotine Dependence
- Trial name
- NCT05434429
- Testing
- mobile application
- Where
- Poland
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PredictWatch
Substance Use Disorders, Opioid Use Disorder
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD)…
- Conditions
- Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder
- Trial name
- EDITOR (NCT06434818)
- Testing
- EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance), CBOT with olfactory stimulants & OFC tasks
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Evon Medics LLC
Cocaine Dependence, Cocaine Addiction
A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction
Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks.
- Trial name
- NCT00567814
- Testing
- Metyrapone, Oxazepam
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Embera NeuroTherapeutics, Inc.
Tobacco Dependence
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking.
- Trial name
- NCT02355665
- Testing
- Nicotine Spray
- Where
- 8 sites in United States
- Volunteers
- 1,198 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Alcoholism
Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
The purpose of this study is to assess the effects of SCH 900435 (Org 25935, MK-8435) on heavy drinking, safety and tolerability of SCH 900435 in participants with alcohol dependence.
- Trial name
- OD-H (NCT00764660)
- Testing
- SCH 900435
- Volunteers
- 141 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
Opioid Dependence, Alcohol Dependence
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.
- Conditions
- Opioid Dependence, Alcohol Dependence, Multiple Sclerosis
- Trial name
- NCT05620940
- Testing
- Vivitrol Injectable Product, IVL3004, IVL4002
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Inventage Lab., 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
Alcohol Use Disorder, Alcohol Dependence
Tech-Enabled CM for AUD at Scale
This Phase II Small Business Innovative Research (SBIR) project is a clinical effectiveness and cost-effectiveness random controlled trial (RCT) of DynamiCare Health's innovative smartphone/smart debit card remote digital…
- Conditions
- Alcohol Use Disorder, Alcohol Dependence, Drug Dependence
- Trial name
- NCT04581499
- Testing
- DynamiCare Motivation Support Program, Untreated or Routine Care Control Group
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- DynamiCare Health
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
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
- Trial name
- NCT01453374
- Testing
- VIVITROL 380mg
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Alkermes, Inc.
Substance Dependence
A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers
Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence.
- Trial name
- NCT00728052
- Testing
- GSK598809
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cocaine Abuse
ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine
The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.
- Trial name
- NCT01366001
- Testing
- ALKS 33-BUP, ALKS 33
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Alkermes, Inc.
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.
Attention Deficit Disorder With Hyperactivity, Amphetamine-Related Disorders
Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse
This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to learn if NRP104 produces a high and any other effects like amphetamine and other stimulant drugs that are abused.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Amphetamine-Related Disorders, Substance-Related Disorders
- Trial name
- NCT00248092
- Testing
- NRP104
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- New River Pharmaceuticals