Cooperative Agreement U01DA066079
- The National Institute on Alcohol Abuse and Alcoholism awarded The Johns Hopkins University $672,377 on September 20, 2025, under the Alcohol Research Programs (CFDA 93.273) to conduct a clinical trial assessing cannabidiol as an adjunct treatment for alcohol withdrawal and craving in patients with alcohol use disorder. The study recruits individuals with moderate-to-severe alcohol use disorder for a four-day inpatient investigation where participants are randomized to receive placebo solution...
- The National Institute on Drug Abuse awarded a $1.65 million cooperative agreement to The University of Texas Southwestern Medical Center on May 15, 2026, to advance pregnenolone as a novel pharmacotherapy for co-occurring cannabis use disorder and depression under the Drug Use and Addiction Research Programs (CFDA 93.279). The award funds clinical research examining pregnenolone's dual therapeutic potential to reduce cannabis use while alleviating depressive symptoms in individuals with both...
- The National Institute on Drug Abuse awarded The Medical University of South Carolina $602,327 on September 1, 2026, under the Drug Use and Addiction Research Programs (CFDA 93.279) to conduct a randomized, placebo-controlled trial of varenicline as a treatment for cannabis use disorder. The trial will enroll participants balanced by sex and randomize them to receive varenicline or placebo, with all participants receiving standardized cognitive behavioral treatment targeting antecedents of...
- The National Institute on Drug Abuse awarded the University of California, San Diego $1,468,376 under the Drug Use and Addiction Research Programs (CFDA 93.279) on July 15, 2026, to conduct a prospective study characterizing sex-specific cannabinoid and endocannabinoid biomarkers as predictors of neuropsychological, behavioral, and withdrawal outcomes during cannabis abstinence in emerging adults. The research will recruit 220 participants aged 18–25 (balanced by sex, 64 percent with heavy...
- The National Institute on Drug Abuse awarded a cooperative agreement totaling $717,986 to Research Foundation For Mental Hygiene, Inc. on May 15, 2026, to test the efficacy of transcutaneous auricular neurostimulation (TAN) in reducing naloxone-precipitated opioid withdrawal symptoms under the Drug Use and Addiction Research Programs (CFDA 93.279). The award funds a randomized, double-blind, sham-controlled clinical trial examining whether non-invasive TAN stimulation of the vagus and trigeminal...
- The National Institute on Drug Abuse, a component of the Department of Health and Human Services, awarded Albert Einstein College of Medicine $252,000 under the Drug Use and Addiction Research Programs (CFDA 93.279) on May 1, 2026. The award funds a 12-week pilot randomized controlled trial (DEMURE Trial) evaluating dronabinol (synthetic THC) and epidiolex (cannabidiol) as adjunctive treatments to buprenorphine for persons with opioid use disorder experiencing protracted withdrawal symptoms...
- The National Institute on Drug Abuse awarded Praeventix LLC $355,190 on June 1, 2026, under the Drug Use and Addiction Research Programs (CFDA 93.279) to conduct in vivo characterization of 5-HT7 modulators in rat models of opioid use disorder. The work evaluates the impact of the lead compound PRA078, a novel 5-HT7 antagonist, on dopamine pathways and cognitive flexibility in animal models of opioid dependence. The research addresses therapeutic gaps in opioid use disorder treatment, where...
- The National Institute on Drug Abuse awarded Cessation Therapeutics, Inc. a Cooperative Agreement of $7.315 million on September 15, 2025, to advance clinical development of CSX-1004, a human IgG1 monoclonal antibody designed to provide prophylaxis against fentanyl and fentanyl analog overdose. The award funds Phase 2 proof-of-concept fentanyl challenge studies in healthy subjects and subjects with opioid use disorder, with the ultimate target product profile being a fixed-dose subcutaneous...
- The National Institute on Drug Abuse awarded The University of Kentucky Research Foundation $647,142 on February 15, 2026, under the Drug Use and Addiction Research Programs (CFDA 93.279) to conduct two randomized, double-blind, placebo-controlled inpatient studies examining how cannabis affects opioid self-administration in individuals with moderate-to-severe opioid use disorder and opioid physical dependence. Study 1 will determine how repeated inhaled cannabis exposure (active cannabis at...
- The National Institute on Drug Abuse, part of the Department of Health and Human Services, awarded Longieva Therapeutics, Inc. $399,989 on August 15, 2026, under the Drug Use and Addiction Research Programs (CFDA 93.279) to conduct Phase I SBIR research evaluating the efficacy of a novel cannabinoid receptor 2 agonist against opioid use disorder. Longieva is developing 36040, a cAMP-biased CB2R agonist designed to mitigate opioid dependence by reducing dopaminergic neuron excitability and...
The National Institute on Drug Abuse awarded a $2.199 million Cooperative Agreement to Pleopharma, Inc. on August 15, 2026, to conduct a Phase 3 clinical trial of PP-01, a novel medication-assisted therapy for cannabis withdrawal syndrome in individuals with cannabis use disorder. The award is funded through the Drug Use and Addiction Research Programs (CFDA 93.279). PP-01 combines a partial CB1 agonist with a gabaergic agent administered in a reverse taper-titration regimen designed to mitigate withdrawal symptoms by targeting endocannabinoid and dopaminergic reward system derangements. Prior Phase 2B data demonstrated statistically significant reductions in withdrawal symptoms compared to placebo, with a 78 percent effect size during peak withdrawal, along with improvements in sleep, cravings, appetite, and cortisol levels. Cannabis withdrawal syndrome represents a critical unmet medical need; currently no FDA-approved medications treat cannabis use disorder or alleviate withdrawal, which drives relapse and undermines behavioral therapy adherence. Performance occurs in Malvern, Pennsylvania, with an ultimate completion date of April 30, 2029. The funding supports clinical, translational, and implementation research to develop new prevention, diagnosis, and treatment approaches for drug use, misuse, and addiction.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $2.2m | 8/12/26 |