Clinical trials: Substance-Related Disorder
Cocaine Use, Cocaine Intoxication
Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)
This is a Phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of TNX-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department…
- Conditions
- Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse
- Trial name
- CATALYST (NCT06045793)
- Testing
- TNX-1300 (Injection)
- Where
- 6 sites in United States
- Volunteers
- 3 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Opioid-induced Constipation
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
- Trial name
- NCT01443403
- Testing
- Naldemedine
- Where
- 49 sites in United States
- Volunteers
- 244 people
- Sponsor
- Shionogi
Drug Addiction
Survey of Buprenorphine Use Among "Out of Care" Population in France (P04933)(COMPLETED)
This study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month.
- Trial name
- NCT00756353
- Volunteers
- 600 people
- Sponsor
- Indivior Inc.
Alcoholism
To Evaluate the Influence of the A118G Polymorphism in the mu Opioid Receptor Gene (OPRM1) on Effects of GSK1521498 and Naltrexone on Physiological and Behavioural Markers of Brain Function in Healthy Social Drinkers
A total of at least 48 healthy subjects with a history of social drinking will be recruited into this single-centre, randomized, double-blind, cross-over study.
- Trial name
- NCT01738867
- Testing
- GSK1521498, Naltrexone (NTX)
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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)
Opioid Induced Constipation
Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain
Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract.
- Trial name
- NCT01207427
- Testing
- ADL5945 0.1 mg, ADL5945 0.25 mg
- Volunteers
- 131 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Age-Related Macular Degeneration
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
This study will evaluate the safety, tolerability, and preliminary efficacy of NG101 AAV gene therapy administered by subretinal injections into a single selected eye as a single selected dose for patients with wet age-related…
- Trial name
- NCT05984927
- Testing
- NG101 AAV gene therapy
- Where
- 4 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Elisigen, Inc.
Opioid Addiction
Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment
Multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to ICD-10 (F11.2), treated with…
- Trial name
- LEVOPROACT (NCT03685162)
- Where
- Italy
- Volunteers
- 103 people
- Sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
Opioid-use Disorder
CBT4CBT for Office Based Buprenorphine
In this Phase II SBIR/STTR project, our Specific Aim will be to determine if the use of CBT4CBT-Buprenorphine leads to clinically significant improved outcomes and increased retention for buprenorphine maintenance patients in a…
- Trial name
- NCT03580902
- Testing
- CBT4CBT-Buprenorphine, Buprenorphine/naloxone
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- CBT4CBT, LLC
Tobacco Dependence
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
- Trial name
- NCT01084603
- Testing
- Oral Nicotine, NiQuitinTM Nicotine Lozenge, Nicorette® Nicotine Gum
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- McNeil AB
Severe Alcoholic Hepatitis
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
This clinical investigation is a substudy within GS-US-416-2124, IND 129570, which is A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus…
- Trial name
- NCT03087968
- Testing
- GS-4997, Prednisolone, HepQuant SHUNT Test
- Where
- 13 sites in United States
- Sponsor
- HepQuant, LLC
Alcohol Impairment, Nystagmus
Alcohol Impairment Detection in Healthy Adult Users With the Gaize Device
This study evaluates the effectiveness of the Gaize virtual reality headset as a non-invasive tool for detecting alcohol-related impairment through ophthalmic and neurological indicators.
- Conditions
- Alcohol Impairment, Nystagmus, Virtual Reality, Lack of Smooth Pursuit
- Trial name
- AAI (NCT07126938)
- Testing
- Alcoholic beverage
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Gaize
Liver Diseases, Alcoholic
A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.
- Trial name
- ALLSTAR (NCT07791043)
- Testing
- Efimosfermin alfa
- Where
- 4 sites in United States, Argentina
- Volunteers
- 274 people
- Sponsor
- GlaxoSmithKline
Social Anxiety Disorder
CHI-902 for Treatment of Social Anxiety Disorder
No substantial clinical trials of Cannabidiol (CBD) in Social Anxiety Disorder (SAD) have yet been conducted. This randomized doubleblind, placebo-controlled trial of CBD in adults with SAD will evaluate the efficacy…
- Trial name
- NCT04086342
- Testing
- CHI-902
- Where
- 2 sites in Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Canopy Growth Corporation
Alcohol Dependence
Safety and Pharmacodynamic Study of GET 73 in Alcohol Dependent
Examination of the effect of GET 73 on alcohol pharmacokinetics and pharmacodynamics (intoxication and sedation)and safety profile in alcohol-dependent individuals.To evaluate whether GET 73, as compared to placebo, results in…
- Trial name
- SPAD (NCT01842503)
- Testing
- GET 73, inactive ingredients capsule
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Laboratorio Farmaceutico Ct S.r.l.
Addiction
A Study to Assess 18-Methoxycoronaridine (18-MC HCl) in Healthy Volunteers
The primary objective of this study is to assess the safety and tolerability of a single day dosing and a separate multiple day dosing of 18-MC HCl administered orally, each part of the study having a different set of healthy…
- Trial name
- NCT04292197
- Testing
- 18-MC Compound
- Where
- Australia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Definium Therapeutics US, Inc.
Opioid-Induced Constipation (OIC)
Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive…
- Trial name
- NCT05588323
- Testing
- Naldemedine
- Where
- 16 sites in Albania, Armenia and 6 more
- Volunteers
- 24 people
- Sponsor
- Shionogi
Substance Use Disorders, Behavioral Health
Mindfulness and Meditation-Based Relapse Prevention for Substance Use Disorders
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs).
- Conditions
- Substance Use Disorders, Behavioral Health, Addiction Psychological, Addiction Disorders
- Trial name
- MBRP-SUD (NCT07417579)
- Testing
- Mindfulness and Meditation-Based Relapse Prevention Program
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Bout Me Healing
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
RETT Syndrome With Proven MECP2 Mutation, Rett Syndrome
Efficacy and Safety of NTI164 in Children and Young Adults With Rett Syndrome
The FENRTT2 study will investigate the efficacy and safety of a medicinal cannabis plant extract with extremely low THC (delta-9-tetrahydrocannabinol), NTI164, on Rett syndrome (RTT) in a crossover design.
- Trial name
- TRANSCEND (NCT07257978)
- Testing
- NTI164
- Where
- Australia
- Volunteers
- 40 people
- Sponsor
- Fenix Innovation Group