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Condition (MeSH)

Tobacco Use Disorder

ClinicalTrials.gov lists 1,022 trials for Tobacco Use Disorder or a narrower condition beneath it. National Institute on Drug Abuse (NIDA) has the most among industry and government lead sponsors, with 68.

MeSH D014029 Chemically-Induced Disorders C25 F03
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Phase 1 Phase 1 96 Phase 1/2 Phase 1/2 27 Phase 2 Phase 2 152 Phase 2/3 Phase 2/3 25 Phase 3 Phase 3 52 Phase 4 Phase 4 95 Not applicable Not applicable 492 Observational Observational 83 Phase 1 Phase 1 96 Phase 1/2 Phase 1/2 27 Phase 2 Phase 2 152 Phase 2/3 Phase 2/3 25 Phase 3 Phase 3 52 Phase 4 Phase 4 95 Not applicable Not applicable 492 Observational Observational 83

Trials per phase

1,022 of the 1,022 trials are tagged with Tobacco Use Disorder itself; the rest are tagged with a narrower condition beneath it.

Get the Tobacco Use Disorder report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Tobacco Use Disorder trials start? (33)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year. 5 trials are registered to start in 2027 or later, and not listed here.

Trials over time, by phase

  • Phase 1
  • Phase 1/2
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 66

1990: 1 trials (Not applicable 1) 1993: 1 trials (Phase 1 1) 1995: 2 trials (Phase 2 2) 1997: 3 trials (Observational 1, Phase 4 1, Phase 2 1) 1998: 5 trials (Not applicable 1, Phase 4 1, Phase 3 1, Phase 2 2) 1999: 8 trials (Observational 1, Not applicable 1, Phase 4 1, Phase 2/3 1, Phase 2 2, Phase 1 2) 2000: 6 trials (Observational 1, Not applicable 2, Phase 4 1, Phase 3 2) 2001: 10 trials (Not applicable 1, Phase 4 4, Phase 3 1, Phase 2 3, Phase 1/2 1) 2002: 13 trials (Observational 3, Not applicable 1, Phase 3 1, Phase 2/3 1, Phase 2 6, Phase 1 1) 2003: 16 trials (Observational 2, Not applicable 4, Phase 3 3, Phase 2 5, Phase 1 2) 2004: 24 trials (Observational 1, Not applicable 7, Phase 4 5, Phase 3 1, Phase 2 6, Phase 1/2 2, Phase 1 2) 2005: 37 trials (Observational 7, Not applicable 10, Phase 4 5, Phase 3 3, Phase 2/3 4, Phase 2 7, Phase 1 1) 2006: 30 trials (Observational 1, Not applicable 8, Phase 4 3, Phase 3 2, Phase 2/3 4, Phase 2 8, Phase 1 4) 2007: 38 trials (Observational 6, Not applicable 19, Phase 4 3, Phase 3 2, Phase 2 4, Phase 1/2 3, Phase 1 1) 2008: 47 trials (Observational 5, Not applicable 19, Phase 4 5, Phase 3 3, Phase 2/3 4, Phase 2 9, Phase 1/2 1, Phase 1 1) 2009: 66 trials (Observational 7, Not applicable 26, Phase 4 5, Phase 3 3, Phase 2/3 2, Phase 2 15, Phase 1 8) 2010: 37 trials (Observational 7, Not applicable 9, Phase 4 5, Phase 3 5, Phase 2/3 1, Phase 2 5, Phase 1/2 2, Phase 1 3) 2011: 53 trials (Observational 2, Not applicable 22, Phase 4 3, Phase 3 7, Phase 2/3 2, Phase 2 6, Phase 1/2 4, Phase 1 7) 2012: 54 trials (Observational 6, Not applicable 21, Phase 4 7, Phase 3 3, Phase 2/3 1, Phase 2 10, Phase 1/2 1, Phase 1 5) 2013: 41 trials (Observational 4, Not applicable 19, Phase 4 3, Phase 3 4, Phase 2 5, Phase 1/2 2, Phase 1 4) 2014: 38 trials (Observational 3, Not applicable 19, Phase 4 2, Phase 3 1, Phase 2 7, Phase 1/2 1, Phase 1 5) 2015: 52 trials (Observational 3, Not applicable 36, Phase 4 6, Phase 3 1, Phase 2/3 1, Phase 2 3, Phase 1 2) 2016: 39 trials (Observational 3, Not applicable 22, Phase 4 2, Phase 3 1, Phase 2 6, Phase 1/2 3, Phase 1 2) 2017: 36 trials (Observational 1, Not applicable 22, Phase 4 2, Phase 3 1, Phase 2/3 1, Phase 2 1, Phase 1 8) 2018: 51 trials (Observational 2, Not applicable 31, Phase 4 3, Phase 3 1, Phase 2 8, Phase 1 6) 2019: 32 trials (Not applicable 18, Phase 4 2, Phase 3 1, Phase 2/3 1, Phase 2 3, Phase 1/2 3, Phase 1 4) 2020: 37 trials (Observational 3, Not applicable 22, Phase 4 3, Phase 3 1, Phase 2 4, Phase 1 4) 2021: 41 trials (Observational 1, Not applicable 26, Phase 4 2, Phase 2/3 1, Phase 2 5, Phase 1/2 3, Phase 1 3) 2022: 33 trials (Observational 1, Not applicable 16, Phase 4 4, Phase 2 4, Phase 1 8) 2023: 40 trials (Observational 2, Not applicable 26, Phase 4 2, Phase 3 1, Phase 2 4, Phase 1/2 1, Phase 1 4) 2024: 47 trials (Observational 5, Not applicable 28, Phase 4 7, Phase 2 4, Phase 1 3) 2025: 34 trials (Observational 3, Not applicable 20, Phase 4 4, Phase 3 1, Phase 2 3, Phase 1 3)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 41
2025 34
2024 47
2023 40
2022 33
2021 41
2020 37
2019 32
2018 51
2017 36

Forecast of the full-year count, planned starts included, not rows of this table: about 50 trials starting in 2026 and about 44 in 2027, the average of the 24 months through September, counted as registered and carried forward, with about 0.7 times the starts already registered for the rest of 2026 added. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 15 percent and ran about 1 percent high against the count later registered; forecasts made before the year began were off by about 26 percent and ran about 20 percent low against the count later registered. The part-way figures are from forecasts that used a multiple fitted only on earlier years. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Prediction, not a registry value: median of 36 months from start to primary completion across 85 trials still running at the 2026-10-09 snapshot; registered median of 29 months across 758 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Tobacco Use Disorder trials in? (8)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 96
Phase 1/2 27
Phase 2 152
Phase 2/3 25
Phase 3 52
Phase 4 95
Not applicable 492
Observational 83

How many Tobacco Use Disorder trials are recruiting? (9)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 25
Recruiting 84
Enrolling by invitation 8
Active, not recruiting 20
Completed 736

Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Tobacco Use Disorder trials? (3)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
National Institute on Drug Abuse (NIDA) 68
McNeil AB 18
VA Office of Research and Development 17

Which drugs are being tested for Tobacco Use Disorder? (1)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
Nicotine Patch 126

Interventions as named in the registry (14)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
varenicline free base 86
BupropionXL 47
Nicotine Replacement Therapy Agent 29
Very Low Nicotine Content (VLNC) Cigarettes 13
Standard Treatment 8

These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Tobacco Use Disorder trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Hospital Readmission 736 1
Hospitalization 500 10
Suicidal ideation 347 6
rehospitalization 310 1
Depression, saddness, grief 238 1

Which publications cover Tobacco Use Disorder? (927)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: prevalence, rare-disease identity, and sub-conditions in mesh.

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