No FDA-approved medication currently exists to treat cocaine use disorder โ making it one of the most challenging addictions to address with pharmacotherapy. Researchers have been searching for decades, and one of the most studied candidates is buprenorphine/naloxone (brand name Suboxone), a combination medication already established for treating opioid use disorder.
The results are nuanced. A major clinical trial called CURB (Cocaine Use Reduction with Buprenorphine) found modest but meaningful signals โ particularly for people who are dealing with both cocaine and opioid use disorders at the same time. Here’s what the research actually shows, who it may apply to, and what treatment options exist today.
Why Treating Cocaine Addiction Is So Difficult
No FDA-Approved Medications Exist for Cocaine Use Disorder
Unlike opioid use disorder (treated with methadone, buprenorphine, or naltrexone) and alcohol use disorder (treated with naltrexone, acamprosate, or disulfiram), cocaine use disorder has no FDA-approved pharmacotherapy as of 2025.
This gap is significant. According to SAMHSA’s 2022 National Survey on Drug Use and Health, approximately 5.3 million Americans aged 12 or older reported past-year cocaine use โ and cocaine-involved overdose deaths have increased sharply in recent years, often driven by fentanyl contamination of the cocaine supply.
Cocaine and the Brain: The Dopamine Challenge
Cocaine produces its intense euphoric effects primarily by flooding the brain with dopamine โ a neurotransmitter that regulates pleasure, reward, and motivation. This dopamine surge is responsible for both the high and the powerful compulsion to use again.
Unlike opioids, which act on specific mu-opioid receptors that can be targeted by medications like buprenorphine in a more direct way, cocaine’s mechanism of action is broader and harder to pharmacologically counteract. Researchers have explored serotonin, GABA, norepinephrine, and the kappa-opioid system as potential targets โ the last of which has led to interest in buprenorphine.
What Is Buprenorphine โ and Why Are Researchers Testing It for Cocaine?
How Buprenorphine Works
Buprenorphine is a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist. It is FDA-approved for treating opioid use disorder and moderate-to-severe pain. When combined with naloxone (as Suboxone), it helps prevent opioid withdrawal and reduces cravings without producing the intense euphoria of full opioid agonists.
Its Schedule III classification reflects its moderate-to-low physical dependence potential compared to full opioids like methadone or heroin.
The Kappa-Opioid Connection to Cocaine Craving
The scientific rationale for testing buprenorphine against cocaine centers on the kappa-opioid receptor system. Researchers theorize that the negative emotional states experienced during cocaine withdrawal โ anxiety, dysphoria, anhedonia โ are driven in part by heightened kappa-opioid activity in the brain.
Because buprenorphine blocks kappa-opioid receptors, the hypothesis is that it could reduce the compulsive craving driven by withdrawal distress. A landmark 1989 study by Mello and Mendelson, published in Science, found that buprenorphine suppressed cocaine self-administration in rhesus monkeys โ and follow-up research confirmed the effect held across treatment periods up to 120 days.
When buprenorphine is combined with naltrexone, naltrexone blocks the mu-opioid receptor stimulation from buprenorphine โ theoretically allowing researchers to selectively harness the kappa-antagonist effect without introducing opioid dependence risk.
The CURB Trial: What the Research Actually Found
Key Context: The CURB trial only enrolled participants with both cocaine use disorder AND a current or past opioid use disorder. The findings do not necessarily apply to people who use cocaine without any opioid involvement.
Study Design
The CURB (Cocaine Use Reduction with Buprenorphine) trial was conducted by NIDA’s Clinical Trials Network and published in the journal Addiction in 2016. It was a multi-site, double-blind, placebo-controlled study enrolling 302 participants across 11 U.S. sites.
Participants were required to meet DSM-IV criteria for cocaine dependence AND have a current or past opioid use disorder. All participants first received an extended-release naltrexone injection (Vivitrol, 380mg) before being randomized into one of three groups for 8 weeks of treatment:
- Group 1: 4mg daily buprenorphine/naloxone (Suboxone)
- Group 2: 16mg daily buprenorphine/naloxone (Suboxone)
- Group 3: Placebo
Primary Outcome Results: A Mixed Picture
The primary outcome, urine drug screen-corrected self-reported cocaine use during the final 4 weeks of treatment, showed no statistically significant differences between any of the three groups.
In plain terms: on the main measure the trial was designed to assess, buprenorphine did not outperform placebo.
Secondary Findings: Where the 16mg Group Showed Promise
A secondary longitudinal analysis of urine drug screen data throughout the study period told a somewhat different story. Participants in the 16mg buprenorphine group showed statistically significant reductions in cocaine-positive screens compared to placebo (p=0.022, OR=1.71) โ meaning 70% greater odds of a negative cocaine test at any given point during treatment.
To put the odds ratio in concrete terms: approximately 45% of screens were cocaine-negative in the placebo group versus 51% in the 16mg buprenorphine group.
Important Caveats
The CURB trial results come with significant caveats that matter for how the findings are interpreted:
- The primary outcome did not reach statistical significance โ the secondary finding is hypothesis-generating, not conclusive.
- Both buprenorphine groups reported higher opioid craving at follow-up compared to placebo, raising a safety concern that warrants further study.
- About 30% of participants in the buprenorphine groups were not fully adherent to the medication regimen.
- The study population had both cocaine AND opioid use disorder โ results may not generalize to people using only cocaine.
The researchers concluded that buprenorphine combined with naltrexone “may be associated with reductions in cocaine use” but that further confirmatory studies are needed before it can be offered as a standard treatment.
Who Might Benefit from Buprenorphine-Based Treatment for Cocaine Use?
The Co-Occurring OUD + Cocaine Population
The strongest case for buprenorphine’s role in cocaine use reduction applies specifically to people who have both opioid use disorder and cocaine use disorder simultaneously โ a population sometimes called “polysubstance” users.
This is clinically significant because cocaine use is common among people in treatment for opioid use disorder. Studies of MAT programs have found that 40โ45% of patients receiving methadone or buprenorphine also use cocaine concurrently. Those who use cocaine alongside opioids are more likely to drop out of treatment and have worse outcomes overall.
Why Treating Opioid Dependence May Indirectly Reduce Cocaine Use
There is also an indirect pathway worth understanding. Many people use cocaine and opioids together in a pattern called speedballing โ injecting or using both drugs simultaneously to intensify or balance each drug’s effects. When opioid use is stabilized through MAT, some patients naturally reduce their cocaine use as well, because the drugs are often used together and the social and behavioral context shifts.
Buprenorphine’s well-documented effectiveness for opioid use disorder may therefore provide indirect cocaine use reduction benefits for co-occurring users, even before any direct anti-cocaine mechanism is established.
Current Treatment Options for Cocaine Addiction
Behavioral Therapies: The Current Standard of Care
In the absence of FDA-approved medications, behavioral therapies are the primary evidence-based treatment for cocaine use disorder. Cognitive Behavioral Therapy (CBT) is the most extensively studied approach, targeting the thought patterns and behavioral triggers associated with cocaine use.
Contingency management โ an approach that provides tangible rewards for confirmed abstinence โ has shown strong effectiveness for cocaine use disorder in multiple studies. Both NIDA and SAMHSA endorse it as a best-practice intervention, with particular strength in stimulant use disorders including cocaine.
Medications Under Investigation
Beyond buprenorphine, researchers are exploring several other pharmacological candidates for cocaine use disorder:
- Modafinil (a wakefulness-promoting agent) has shown mixed results in trials.
- Topiramate (an anticonvulsant) has demonstrated some effectiveness in reducing cocaine use in certain populations.
None of these have achieved FDA approval for cocaine use disorder as of 2025. The most significant active trial is CURB-2 (CTN-0109), a NIDA-funded follow-on to the original CURB study, currently testing injectable extended-release formulations of buprenorphine and naltrexone โ an approach designed to address the medication adherence limitations seen with oral Suboxone in the original trial.
The field continues to evolve, and personalized pharmacotherapy approaches โ matching medication to individual neurobiological profiles โ represent a promising direction.
Comprehensive Treatment at Discover Recovery
At Discover Recovery, we offer evidence-based treatment for cocaine addiction and co-occurring substance use disorders. Our programs integrate Cognitive Behavioral Therapy, Medication-Assisted Treatment (MAT) where clinically appropriate, and individualized treatment planning to address the full complexity of each patient’s needs.
If you or someone you love is struggling with cocaine use disorder our team of board-certified addiction medicine physicians can discuss the latest treatment options in a confidential assessment. Discover Recovery is CARF-accredited and licensed by the Washington State Department of Health.
Contact us today at 866.719.2173 or complete our insurance verification form to get started.
Frequently Asked Questions
Is buprenorphine FDA-approved for cocaine addiction?
No. As of 2025, no medication is FDA-approved specifically for cocaine use disorder. Buprenorphine (Suboxone) is FDA-approved only for opioid use disorder and pain management. Its potential role in cocaine treatment is based on clinical research โ particularly the CURB trial โ but remains investigational.
Can Suboxone help with cocaine cravings?
The evidence is limited and mixed. The CURB trial found no statistically significant difference on its primary outcome, though a secondary analysis showed modestly fewer cocaine-positive drug screens for participants taking 16mg daily. Suboxone may be most relevant for people who use both cocaine and opioids, where treating the opioid use disorder may also reduce cocaine use indirectly.
Who was the CURB trial designed to help?
The CURB trial specifically enrolled people who met criteria for both cocaine dependence AND opioid use disorder (current or past). It was not designed โ and results should not be extrapolated โ for people who only use cocaine without any opioid involvement. This is an important distinction that is often overlooked in summaries of the research.
What treatments actually work for cocaine addiction today?
Cognitive Behavioral Therapy (CBT) and contingency management (providing incentives for confirmed abstinence) are the most evidence-supported treatments for cocaine use disorder. No medications are currently FDA-approved, though several are under active investigation. A comprehensive treatment program combining therapy, medical oversight, and peer support offers the best outcomes.
Does buprenorphine work for people who only use cocaine and not opioids?
Current evidence does not support using buprenorphine for people who only use cocaine. The CURB trial excluded opioid-naive individuals specifically to avoid exposing them to an opioid drug unnecessarily. Any use of buprenorphine in cocaine-only patients would be off-label and not supported by current clinical evidence.
What should I do if I or someone I love is struggling with cocaine addiction?
Seek a professional evaluation from an addiction medicine specialist who can assess the full picture โ including any co-occurring opioid, alcohol, or mental health issues. Behavioral therapies like CBT are effective, and a comprehensive treatment center can develop an individualized plan. Contact Discover Recovery at 866.719.2173 for a confidential conversation about your options.
Final Takeaway
The lack of effective medications for cocaine use and dependence underscores the need to promote further pharmacological research. This will hopefully translate into real-world treatments for cocaine dependence. Findings of studies suggest that buprenorphine is beneficial in reducing cocaine use, but larger, randomized, blinded trials are needed in individuals with a primary cocaine dependence before buprenorphine can be offered as a standard treatment for cocaine use disorder.
Reviewed By: Dr. Kevin Fischer, M.D.
Kevin Fischer, MD is an experienced leader in the fields of Internal Medicine and Addiction Medicine. He works with patients suffering from Substance Use Disorder to evaluate their comprehensive health needs and prescribe Medication-Assisted Treatment (MAT). In addition, he mentors aspiring health professionals and leads collaborative care through team-based medical models. He also directs treatment strategies and streamlines clinical protocols for effective substance use recovery.