CLINICAL TRIALS PROFILE FOR CAMPRAL

All Clinical Trials for CAMPRAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006206 ↗	COMBINE (Acamprosate/Naltrexone)	Completed	Lipha Pharmaceuticals	Phase 3	1997-08-01	Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.
NCT00006206 ↗	COMBINE (Acamprosate/Naltrexone)	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 3	1997-08-01	Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.
NCT00006206 ↗	COMBINE (Acamprosate/Naltrexone)	Completed	University of North Carolina, Chapel Hill	Phase 3	1997-08-01	Combine is a multicenter, randomized clinical trial that will evaluate combinations of three interventions for treating alcohol dependence. The goal is to determine whether improvement in treatment outcomes can be achieved by various combinations of drug and behavioral interventions. Two of the interventions will consist of pharmacological treatment with naltrexone (Revia) or acamprosate (Campral). The third intervention is a multicomponent behavioral therapy including such components as motivational enhancement therapy, cognitive behavioral therapy, and referral to self-help groups, including AA. All three interventions will include a component supporting compliance to medications and reduction in drinking.
NCT00106106 ↗	Acamprosate to Reduce Symptoms of Alcohol Withdrawal	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2005-03-01	This study will examine whether a new drug called acamprosate can be helpful for alcohol withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression, tremor, high blood pressure, and others. During withdrawal, brain chemicals called neurotransmitters change, with some rising to abnormally high levels. These changes may contribute to alcohol craving, drinking relapse and impaired mental performance. This study will see if taking acamprosate for 4 weeks can lower the levels of neurotransmitters, such as glutamate, lessen withdrawal symptoms and decrease alcohol craving and brain damage associated with withdrawal. Healthy normal volunteers and alcohol-dependent patients between 21 and 65 years of age may be eligible for this study. Participants are admitted to the hospital for 28 days. They receive standard inpatient care for alcohol detoxification, including a medical history and physical examination, neurological evaluation, laboratory tests, nursing, nutrition, discharge planning and referrals for treatment of concomitant conditions, if needed. In addition, they are randomly assigned to take either two acamprosate or two placebo pills three times a day for 28 days and undergo the following tests and procedures: - Days 1-28: Drug treatment. Patients take acamprosate or placebo daily. Patients with severe withdrawal symptoms may also receive diazepam (Valium). Throughout their hospitalization, patients fill out questionnaires about their emotional state and personality and are interviewed by staff about their mental health, use of alcohol, cigarettes, and illicit drugs, employment, support systems and family and social relationships, and their legal status. - Days 2 and 3: Blood tests. Blood is tested for levels of the stress hormones cortisol and ACTH, which are released to excess during alcohol withdrawal. For this test, a heparin lock (thin, flexible plastic tube with a rubber stopper on the end) is placed in an arm vein for blood collections each day at 6 AM, 12 noon, 6 PM and 12 midnight. Patients rest in bed for 30 minutes before each collection. - Day 4: Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These procedures are done at the same time. They use a strong magnetic field and radio waves to show structural and chemical changes in the brain. The patient lies on a table in a space enclosed by a metal cylinder (the scanner) for about 20 to 30 minutes during the test. - Day 5: Lumbar puncture (spinal tap). A local anesthetic is given to numb the area for the procedure. Then, a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. - Days 5 and 6: Dexamethasone-corticotropin releasing factor (CRF) test. This test measures the effect of alcohol withdrawal on ACTH and cortisol. The patient takes a standard dose of the steroid dexamethasone at 11 PM on day 5. At noon the next day, they are given lunch and then stay in bed and rest. A plastic tube is put in an arm vein. A salt water solution is slowly infused through the catheter and a blood sample is withdrawn through it. At 3 p.m., the patient is given 100 micrograms of the hormone CRF. Repeated blood samples are obtained to measure ACTH and cortisol. - Days 23-27: All of the tests done on days 2-6 are repeated, except the MRI. MRS is repeated to measure neurotransmitters.
NCT00106106 ↗	Acamprosate to Reduce Symptoms of Alcohol Withdrawal	Completed	National Institutes of Health Clinical Center (CC)	Phase 2	2005-03-01	This study will examine whether a new drug called acamprosate can be helpful for alcohol withdrawal, a result of drinking high amounts of alcohol for long periods of time. Alcohol withdrawal can cause various symptoms, including nausea or vomiting, anxiety or depression, tremor, high blood pressure, and others. During withdrawal, brain chemicals called neurotransmitters change, with some rising to abnormally high levels. These changes may contribute to alcohol craving, drinking relapse and impaired mental performance. This study will see if taking acamprosate for 4 weeks can lower the levels of neurotransmitters, such as glutamate, lessen withdrawal symptoms and decrease alcohol craving and brain damage associated with withdrawal. Healthy normal volunteers and alcohol-dependent patients between 21 and 65 years of age may be eligible for this study. Participants are admitted to the hospital for 28 days. They receive standard inpatient care for alcohol detoxification, including a medical history and physical examination, neurological evaluation, laboratory tests, nursing, nutrition, discharge planning and referrals for treatment of concomitant conditions, if needed. In addition, they are randomly assigned to take either two acamprosate or two placebo pills three times a day for 28 days and undergo the following tests and procedures: - Days 1-28: Drug treatment. Patients take acamprosate or placebo daily. Patients with severe withdrawal symptoms may also receive diazepam (Valium). Throughout their hospitalization, patients fill out questionnaires about their emotional state and personality and are interviewed by staff about their mental health, use of alcohol, cigarettes, and illicit drugs, employment, support systems and family and social relationships, and their legal status. - Days 2 and 3: Blood tests. Blood is tested for levels of the stress hormones cortisol and ACTH, which are released to excess during alcohol withdrawal. For this test, a heparin lock (thin, flexible plastic tube with a rubber stopper on the end) is placed in an arm vein for blood collections each day at 6 AM, 12 noon, 6 PM and 12 midnight. Patients rest in bed for 30 minutes before each collection. - Day 4: Magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). These procedures are done at the same time. They use a strong magnetic field and radio waves to show structural and chemical changes in the brain. The patient lies on a table in a space enclosed by a metal cylinder (the scanner) for about 20 to 30 minutes during the test. - Day 5: Lumbar puncture (spinal tap). A local anesthetic is given to numb the area for the procedure. Then, a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. - Days 5 and 6: Dexamethasone-corticotropin releasing factor (CRF) test. This test measures the effect of alcohol withdrawal on ACTH and cortisol. The patient takes a standard dose of the steroid dexamethasone at 11 PM on day 5. At noon the next day, they are given lunch and then stay in bed and rest. A plastic tube is put in an arm vein. A salt water solution is slowly infused through the catheter and a blood sample is withdrawn through it. At 3 p.m., the patient is given 100 micrograms of the hormone CRF. Repeated blood samples are obtained to measure ACTH and cortisol. - Days 23-27: All of the tests done on days 2-6 are repeated, except the MRI. MRS is repeated to measure neurotransmitters.

Clinical Trial Conditions for CAMPRAL

Condition Name

Condition Name for CAMPRAL
Intervention	Trials
Alcohol Dependence	8
Alcoholism	5
Schizophrenia	2
Bipolar Disorder	2

Condition MeSH

Condition MeSH for CAMPRAL
Intervention	Trials
Alcoholism	13
Syndrome	2
Fragile X Syndrome	2
Bipolar Disorder	2

Clinical Trial Locations for CAMPRAL

Trials by Country

Trials by Country for CAMPRAL
Location	Trials
United States	32
Germany	1

Trials by US State

Trials by US State for CAMPRAL
Location	Trials
Ohio	3
Maryland	3
South Carolina	3
Pennsylvania	3
New York	2

Clinical Trial Progress for CAMPRAL

Clinical Trial Phase

Clinical Trial Phase for CAMPRAL
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CAMPRAL
Clinical Trial Phase	Trials
Completed	20
Terminated	2
Recruiting	1

Clinical Trial Sponsors for CAMPRAL

Sponsor Name

Sponsor Name for CAMPRAL
Sponsor	Trials
Forest Laboratories	8
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	6
University of North Carolina, Chapel Hill	2

Sponsor Type

Sponsor Type for CAMPRAL
Sponsor	Trials
Other	29
NIH	9
Industry	9

Last updated: July 28, 2026

Campral (acamprosate) clinical trials update, market analysis, and sales projection

Campral is the brand name for acamprosate (acetylhomotaurine), an oral agent used to maintain abstinence in alcohol use disorder (AUD). As of the latest publicly indexed sources, Campral’s clinical-trials footprint is limited relative to newer AUD pharmacotherapies; the market is dominated by generic acamprosate in many regions, which compresses brand economics. Forecasting brand sales for Campral depends on geography, branded-price maintenance policies, and local reimbursement, because patent-driven exclusivity is largely not present in major markets.

Scope note

This profile focuses on clinical-trials activity trends, commercial dynamics, and market outlook for Campral/acamprosate where public sources provide usable, time-bounded data.

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What is the latest clinical trials update for Campral (acamprosate) in alcohol use disorder?

Primary status: Campral is an older AUD therapy with ongoing observational and real-world studies in some regions and periodic clinical evaluations, typically focused on:

• adherence, retention in treatment, and abstinence durability
• predictors of response (baseline drinking pattern, liver function, comorbidities)
• switching and combination strategies with psychosocial care
• dose optimization and tolerability in special populations

Interventional activity pattern: Compared with AUD drugs that have recent phase 2/3 programs (eg, naltrexone formulations, acamprosate-analog development programs), Campral’s pipeline presence is usually characterized by:

• smaller-scale trials
• pragmatic designs
• outcomes aligned with abstinence maintenance and relapse reduction
• limited late-stage (registrational) activity in major jurisdictions

Trial endpoints most commonly reported

Across Campral studies, sponsors and investigators typically track:

• time to first relapse
• proportion maintaining abstinence at 3, 6, and 12 months
• heavy drinking days (HDD) and drinking outcomes (where abstinence maintenance is not the sole endpoint)
• treatment discontinuation due to adverse events and adherence

What counts as “update” in Campral’s evidence base

For Campral, the practical “update” is less about new efficacy signals and more about:

• consistency across cohorts and delivery settings
• adherence and persistence under routine care
• subgroup performance (renal impairment tolerability and dose constraints, comorbid depression/anxiety populations)

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Which recent trials are evaluating Campral, and what do they test?

Publicly indexed studies for acamprosate in AUD generally fall into four recurring categories:

1) Adherence and persistence in real-world settings

These studies evaluate:

• continuation rates after initiation
• effects of pharmacy access, patient support, and counseling intensity
• reasons for discontinuation

2) Combination or sequencing strategies

Campral is frequently assessed as:

• a background medication with psychosocial interventions
• part of a broader regimen that may include anti-craving agents in some protocols

3) Special populations

Common subgroups include:

• patients with liver disease risk (within labeling constraints)
• patients with renal impairment (dose adjustment and safety monitoring)
• patients with comorbid psychiatric conditions

4) Comparative effectiveness against other AUD regimens

These include:

• comparative cohorts in observational datasets
• pragmatic comparisons where endpoints mirror routine clinical outcomes

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How strong is Campral’s clinical efficacy evidence versus naltrexone and disulfiram?

Relative efficacy framing used in practice:

• Naltrexone and other anti-craving therapies are often positioned for reducing heavy drinking in certain populations.
• Campral is positioned for abstinence maintenance, especially after detoxification or initial abstinence.

Evidence hierarchy: Campral has a long clinical record based on earlier controlled trials, and most “strength” discussions now turn on:

• baseline drinking severity and abstinence status
• comorbidity and relapse pattern
• adherence feasibility in real-world care

Practical differentiator: Campral’s therapeutic fit is typically strongest when a patient is already abstinent and the goal is maintaining abstinence, not primarily reducing drinking intensity while continuing to drink.

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What is the Orange Book status of Campral (acamprosate) and does it face generic entry risk?

Campral is acamprosate. In the US, generic acamprosate is widely available, which indicates that brand exclusivity is not a major near-term barrier to generic supply.

Featured snippet answer: Campral’s US brand exclusivity does not materially constrain generic availability for acamprosate in the US market because generics exist broadly.

Orange Book dynamics (how exclusivity typically plays out for older drugs)

For older small molecules like acamprosate, business-relevant realities are:

• primary composition and early manufacturing patents are long expired
• any remaining coverage is often via formulation/process claims or jurisdiction-specific “last mile” IP
• even when patents exist, generic market entry usually already occurred, so the key risk is primarily litigation/territory pricing rather than first-wave launches

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When does Campral lose exclusivity internationally and what does that mean for brand pricing?

Campral’s exclusivity is largely historical in major markets. The commercial effect is:

• branded share is constrained by generic substitution and pharmacy benefit design
• branded price maintenance depends on reimbursement rules, tendering behavior, and region-level brand support

Business implication by region archetype

• US: Generic acamprosate supply is established; brand share is pricing-sensitive.
• EU/UK: Many markets have entrenched generics; tenders often compress prices further.
• Rest of world: Brand economics depend on local approval status and the timing of generic registrations.

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How many patents protect Campral (acamprosate), and what types of patents matter today?

For established older molecules:

• the relevant IP estate is usually limited to process, polymorph, salt/formulation, and method-of-use claims that may survive longer in some jurisdictions
• however, because generics already exist widely, the remaining value is often in litigation leverage for specific territories or products, not in stopping generic supply entirely

Patent estate practical categories for acamprosate

1. Process/manufacturing patents for specific steps, yields, or intermediates
2. Formulation patents (tablet properties, coating, excipients)
3. Method-of-use claims tied to specific AUD subpopulations or treatment algorithms

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What patent litigation affects Campral or generic acamprosate filings (Paragraph IV and beyond)?

Paragraph IV litigation is most relevant for US brand-vs-generic disputes. For older drugs with broad generic availability, the typical status is:

• fewer current first-wave litigations
• potential disputes may arise around later-stage formulations or product-specific generics in certain territories

Featured snippet answer: The major commercial driver for Campral is not ongoing US patent litigation, but generic pricing and access dynamics in routine care.

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What generic entry risks exist for Campral (acamprosate) in 2026–2028?

Because generics already exist in major markets, “entry risk” is better framed as:

• price erosion due to incremental generic entrants and capacity expansions
• margin pressure from reimbursement tendering and reference pricing
• supply risk (manufacturing capacity and quality systems) that can create periodic price volatility

Forecast effect

Even without new generics, market forces reduce brand leverage; the main variable for 2026–2028 is pricing through:

• payer switching and pharmacy substitution
• tender rounds and contract renewals
• competitor volume growth and inventory cycles

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What formulations are protected for Campral, and do they affect substitution?

Campral’s market substitution typically occurs at the level of:

• active ingredient identity: acamprosate
• dosing form equivalence: oral tablets (and other local presentations depending on jurisdiction)

Residual formulation IP tends to matter when:

• a brand has a differentiated dosing form that changes bioavailability or dosing convenience
• generics are forced into design-around reformulations that can be slower to qualify

In practice for acamprosate, substitution is usually straightforward, given entrenched generic availability.

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What is the current market size for acamprosate (Campral) by geography?

Data availability constraint: Public, brand-level revenue figures for Campral are not consistently disclosed when generic accounts dominate the category, and in many markets, the branded product is a small share of total acamprosate volume.

Commercial segmentation that is decision-useful:

• US: established generic market; brand share depends on contracts and distribution.
• EU (major markets): generic-heavy; category demand depends on AUD prevalence, adherence rates, and reimbursement policy.
• Rest of world: brand share can be higher where generics are less entrenched, and where AUD treatment access is improving.

Market demand drivers

• rising recognition and diagnosis of AUD
• inpatient detoxification and linkage-to-care pathways
• payer coverage for pharmacotherapy plus counseling
• clinician comfort and guideline alignment with abstinence maintenance strategy

Market supply drivers

• generic manufacturing capacity and quality throughput
• tender pricing cycles
• substitution policies at pharmacy level

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What is the revenue outlook and sales projection for Campral (acamprosate) through 2028?

Featured snippet answer: Category volume demand is supported by AUD treatment penetration, but sales growth is structurally limited by generic price compression. The most realistic trajectory is flat-to-slight decline in branded net sales with stable or modestly growing category units, depending on regional access improvements.

Projection framework (what moves the number)

1. Branded price realization: payer policies, tender outcomes, patient co-pay.
2. Brand share: influenced by switching incentives and formulary placement.
3. Generic share shift: driven by new entrants and contracted supply.
4. Overall AUD treated population: influenced by diagnosis rates and care pathways.

Base-case direction (2026–2028)

• Branded Campral: downward or flat net sales in markets with aggressive generic substitution.
• Category acamprosate: low-to-moderate growth in units in regions with improving AUD treatment adoption, offset by continued price compression.

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How does Campral compare commercially with other AUD drugs (naltrexone, acamprosate, disulfiram) in managed care?

Commercial comparison usually breaks by payer strategy:

• naltrexone and extended-release options can be more attractive when adherence support is needed
• disulfiram is often used in limited, clinician-supervised contexts due to adherence and disincentive structure
• acamprosate (Campral) fits abstinence maintenance and guideline pathways for patients who can achieve abstinence after detox

Market consequence: even with stable clinical utility, Campral’s economics are constrained by generic substitution.

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Key takeaways

• Campral (acamprosate) remains a clinically established AUD therapy focused on abstinence maintenance; new “clinical breakthroughs” are uncommon in late-stage interventional programs.
• The near-term commercial outlook is shaped more by generic pricing and access than by brand exclusivity or new trial efficacy.
• Sales projection for branded Campral through 2028 is most consistent with flat-to-declining net sales in generic-heavy markets, with category units supported by ongoing AUD treatment penetration.
• Patent and exclusivity leverage is not the primary driver in 2026–2028 given entrenched generic availability.

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FAQs

1) Is Campral (acamprosate) still recommended in AUD guidelines in 2026?
Yes. It remains used for abstinence maintenance in patients who achieve initial abstinence, particularly where psychosocial treatment is also provided.

2) Does Campral work if a patient has not fully detoxed?
Clinical positioning emphasizes use after abstinence is achieved; effectiveness is typically discussed in relation to abstinence maintenance rather than ongoing drinking reduction.

3) What are the main safety monitoring points for acamprosate?
Renal function and tolerability drive monitoring, with dose constraints in renal impairment.

4) Can Campral be combined with psychosocial therapy, and does it improve outcomes?
Most treatment paradigms pair medication with counseling. Clinical benefit is generally discussed in combined care contexts.

5) Will new clinical trials likely change Campral’s market position?
Large market re-rating from late-stage registrational results is unlikely; the market position is more likely to evolve through access, adherence, and payer uptake rather than new mechanism-based differentiation.

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References (APA)

1. World Health Organization. (n.d.). Alcohol use disorders: Guidelines and management resources. WHO.
2. ClinicalTrials.gov. (n.d.). Acamprosate studies in alcohol use disorder. U.S. National Library of Medicine.
3. FDA. (n.d.). Drug approvals and labeling resources for acamprosate-containing products. U.S. Food and Drug Administration.
4. EMA. (n.d.). Assessment history and product information for acamprosate. European Medicines Agency.
5. NICE. (n.d.). Alcohol-use disorders: management guidance. National Institute for Health and Care Excellence.