Clinical trials: Drug Withdrawal
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 Withdrawal
Open-Label, Safety Study of Lofexidine
The purpose of this Phase 3 open-label treatment study is to evaluate the safety and effectiveness of lofexidine at a clinically relevant dose to alleviate symptoms of acute withdrawal from any opioid, including methadone and…
- Trial name
- NU LEAF (NCT02363998)
- Testing
- Lofexidine
- Where
- 18 sites in United States
- Volunteers
- 286 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Hyperkalemia
Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.
- Trial name
- DIAMOND (NCT03888066)
- Testing
- Patiromer
- Where
- 415 sites in United States, Argentina and 19 more
- Volunteers
- 1,195 people
- Sponsor
- Vifor Pharma, Inc.
Opioid Dependence, Acute Opioid Withdrawal Syndrome
Efficacy, Safety and Dose-Response Study Followed by Open-Label Study of Lofexidine Treatment of Opioid Withdrawal
The purpose of this study is to look at the efficacy and safety for lofexidine hydrochloride, an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.
- Trial name
- NCT01863186
- Testing
- Lofexidine HCl, Open Label Lofexidine HCL
- Where
- 18 sites in United States
- Volunteers
- 603 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
Tardive Dyskinesia (TD)
The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine
This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.
- Trial name
- NCT03698331
- Testing
- Valbenazine
- Where
- 17 sites in United States, Puerto Rico
- Volunteers
- 89 people
- Sponsor
- Neurocrine Biosciences
Osteoarthritis of the Knee
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.
- Trial name
- NCT01444365
- Testing
- ABT-652 NSAID
- Where
- 31 sites in United States
- Volunteers
- 202 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Neuralgia, Postherpetic, Diabetic Neuropathy
Neuropathic Pain Syndrome Patient Study (MK-0000-072)
The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
- Conditions
- Neuralgia, Postherpetic, Diabetic Neuropathy, Painful Small-Fiber Neuropathy, Idiopathic Distal Sensory Polyneuropathy
- Trial name
- NCT00570310
- Testing
- Comparator: pregabalin
- Volunteers
- 104 people
- Sponsor
- Merck Sharp & Dohme LLC
Opioid Dependency
Re-Treatment Study of Probuphine in Opioid Addiction
Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence.
- Trial name
- NCT01262261
- Testing
- Probuphine (buprenorphine implant)
- Where
- 18 sites in United States
- Volunteers
- 85 people
- Sponsor
- Titan Pharmaceuticals
Chronic Non-specific Low Back Pain
Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Non-specific Low Back Pain
Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic…
- Trial name
- NCT04940741
- Testing
- VER-01
- Where
- Germany
- Volunteers
- 820 people
- Sponsor
- Vertanical GmbH
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.
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Trial name
- NCT07314346
- Testing
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Neonatal Opioid Withdrawal Syndrome
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
A Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
- Trial name
- NOWSHINE (NCT04104646)
- Testing
- CHF6563, Morphine
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Pain, Low Back Pain
A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
- Conditions
- Chronic Pain, Low Back Pain, Analgesia
- Trial name
- NCT01571362
- Testing
- ALO-02
- Where
- 52 sites in United States
- Volunteers
- 410 people
- Sponsor
- Pfizer
Cancer Related Pain
NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers
This is a multi-centre, long term, double blind, clinical protocol for NanaBis™ as a monotherapy treatment in participants 18-75 years of age with cancer related pain.
- Trial name
- NCT04808531
- Testing
- NanaBis™, Oxycodone CR, Oxycodone IR
- Volunteers
- 360 people
- Sponsor
- Medlab Clinical
Opioid Use Disorder, Opioid Withdrawal
Suboxone Dispenser for OUD
The goal of this study is to evaluate the usability and acceptability of the Addinex system with patients receiving Suboxone in OUD treatment.
- Trial name
- NCT05790551
- Testing
- Addinex
- Where
- United States
- Sponsor
- Addinex Technologies, Inc.
Chronic Pain
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
- Trial name
- NCT01100437
- Testing
- EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Pfizer
Opioid Withdrawal (Disorder)
Randomized, Double-Blind, Placebo-Controlled Pilot Study on the Safety and Effectiveness of LUCEMYRA During an Opioid Taper in Treatment of Withdrawal
Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
- Trial name
- TAPER (NCT04070157)
- Testing
- Lofexidine
- Where
- 12 sites in United States
- Volunteers
- 4 people
- Sponsor
- USWM, LLC (dba US WorldMeds)
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
Opioid-use Disorder, Opioid Withdrawal
Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder
The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone during Phase II.
- Trial name
- RESTORE (NCT05053503)
- Testing
- Sparrow Ascent Therapy System, Lofexidine, Extended-release injectable naltrexone
- Where
- 4 sites in United States
- Volunteers
- 108 people
- Sponsor
- Spark Biomedical, Inc.
Opioid Dependence
Extension to Safety and Efficacy of Probuphine in the Treatment of 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-807 (NCT00630201)
- Testing
- Probuphine (buprenorphine implant)
- Where
- 15 sites in United States
- Volunteers
- 62 people
- Sponsor
- Titan Pharmaceuticals