Clinical trials: Substance Dependence
Alcoholism
ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as…
- Trial name
- NCT01218997
- Testing
- Medisorb naltrexone 380 mg, Oral naltrexone 50 mg
- Volunteers
- 436 people
- Sponsor
- Alkermes, 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
Opioid Dependence
INDV-2000 First in Human
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction…
- Trial name
- NCT04413552
- Testing
- INDV-2000
- Where
- United States
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Indivior Inc.
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 Dependence
A Study of Adult Outpatients With Opioid Dependence Transitioned From a Daily SL Buprenorphine to Probuphine® Subdermal Implants
The primary objective of the study is to demonstrate maintenance of treatment efficacy when transferring adult outpatients with opioid dependence, who are clinically stabilized on 8 mg or less of sublingual (SL) buprenorphine…
- Trial name
- PRO-814 (NCT02180659)
- Testing
- sublingual buprenorphine tablets, Buprenorphine implant
- Volunteers
- 177 people
- Sponsor
- Titan Pharmaceuticals
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.
Opioid Use Disorder
Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)
This study will evaluate the safety, effectiveness and tolerance of low doses of oral naltrexone along with buprenorphine to treat opioid use disorder prior to the first injection of VIVITROL.
- Trial name
- NCT02537574
- Testing
- NTX/BUP, NTX/PBO-B, PBO-N/PBO-B
- Where
- 20 sites in United States
- Volunteers
- 380 people
- Sponsor
- Alkermes, Inc.
Opioid Dependence
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population
The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4.
- Trial name
- NCT02038790
- Testing
- Suboxone Sublingual Film, Zubsolv sublingual tablets
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Indivior Inc.
Alcohol Dependence
Efficacy of Nalmefene in Patients With Alcohol Dependence
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
- Trial name
- ESENSE2 (NCT00812461)
- Testing
- Nalmefene
- Where
- 57 sites in Belgium, Czechia and 5 more
- Volunteers
- 678 people
- Sponsor
- H. Lundbeck A/S
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
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.
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.
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, 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.
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
Opioid-Related Disorders, Opiate Dependence
Study to Assess Efficacy and Safety of BNX Sublingual Tablets for the Induction of Treatment of Opioid Dependence
The purpose of the study was to assess the efficacy of induction treatment with buprenorphine/naloxone (BNX) sublingual tablet s compared with induction treatment with buprenorphine only.
- Trial name
- NCT01848054
- Testing
- Buprenorphine/naloxone sublingual tablets, Buprenorphine
- Where
- 14 sites in United States
- Volunteers
- 313 people
- Sponsor
- Orexo AB
Smoking Cessation, Harm Reduction
Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes
This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked.
- Conditions
- Smoking Cessation, Harm Reduction, E-Cig Use, Cigarette Smoking
- Trial name
- RECON (NCT04188197)
- Testing
- JUUL
- Where
- 2 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Opioid Related Disorder
Multiple Dose Pharmacokinetics Depot Buprenorphine in Opioid-Dependent Subjects
This is an open-label study in treatment seeking opioid-dependent subjects for safety, tolerability, pharmacokinetics (PK), efficacy markers, and opioid receptor availability of subcutaneous injections of depot buprenorphine…
- Trial name
- NCT01738503
- Testing
- RBP-6000, Subutex
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Indivior Inc.