Evidence map›Paper›PMID 26711160›Full record

Trial reportDrug and alcohol dependence2016

Dronabinol and lofexidine for cannabis use disorder: A randomized, double-blind, placebo-controlled trial.

Frances R Levin, John J Mariani, Martina Pavlicova, Daniel Brooks, Andrew Glass, Amy Mahony, Edward V Nunes, Adam Bisaga, Elias Dakwar, Kenneth M Carpenter and 2 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug and alcohol dependence, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 9 pooled it
7.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 9 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Guideline
  2. Pharmacotherapies for cannabis use disorder.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pharmacotherapies for cannabis dependence.The Cochrane database of systematic reviews · 2019
    Pooled it
  8. Pooled it
  9. Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Article
  16. Pharmacotherapy for Cannabis Use Disorder: Preclinical and Clinical Models.Current topics in behavioral neurosciences · 2026
    Review
  17. Review
  18. Review
  19. Review
  20. ΔJournal of clinical medicine · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 1 country.

Frances R LevinNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168th Street, New York, NY 10032, United States. Electronic address: frl2@columbia.edu.
John J MarianiNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168th Street, New York, NY 10032, United States.
Martina PavlicovaDepartment of Biostatistics, Columbia University, 722 West 168th Street, New York, NY 10032, United States.
Daniel BrooksNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States.
Andrew GlassNew York State Psychiatric Institute, Division of Biostatistics, 1051 Riverside Drive, New York, NY 10032, United States.
Amy MahonyNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States.
Edward V NunesNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168th Street, New York, NY 10032, United States.
Adam BisagaNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168th Street, New York, NY 10032, United States.
Elias DakwarNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168th Street, New York, NY 10032, United States.
Kenneth M CarpenterNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168th Street, New York, NY 10032, United States.
Maria A SullivanNew York State Psychiatric Institute, Division of Substance Abuse, 1051 Riverside Drive, New York, NY 10032, United States; Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 630 West 168th Street, New York, NY 10032, United States.
Jean C ChoiNew York State Psychiatric Institute, Division of Biostatistics, 1051 Riverside Drive, New York, NY 10032, United States.
New York State Psychiatric InstituteColumbia University · USNew York State Office of Alcoholism and Substance Abuse Services · US

Funding

PHARMACOLOGICAL TREATMENT OF MARIJUANA DEPENDENCEP50DA009236 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI KLEBER, HERBERT DAVID · 1994 to 2013
$39.4M
Substance Abuse Treatment Development and Clinical Research MentoringK24DA029647 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LEVIN, FRANCES RUDNICK · 2010 to 2019
$1.8M
TREATMENT OF SUBSTANCE ABUSE AND PSYCHIATRIC COMORBIDITYK02DA000465 · NIDA · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LEVIN, FRANCES RUDNICK · 2000 to 2009
$1.2M
NIDA NIH HHS K02 DA000465NIDA NIH HHS K24 DA029647NIDA NIH HHS P50 DA009236NIDA NIH HHS P50DA09236PHS HHS K02 000465
6 · The paper itself

Abstract

backgroundCannabis use disorder is associated with substantial morbidity and, after alcohol, is the most common drug bringing adolescents and adults into treatment. At present, there are no FDA-approved medications for cannabis use disorder. Combined pharmacologic interventions might be particularly useful in mitigating withdrawal symptoms and promoting abstinence.

objectiveThe purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, and lofexidine, an alpha-2 agonist, in treating cannabis dependence.

methodsOne hundred fifty six cannabis-dependent adults were enrolled and following a 1-week placebo lead-in phase 122 were randomized in a double-blind, placebo-controlled, 11-week trial. Participants were randomized to receive dronabinol 20mg three times a day and lofexidine 0.6 mg three times a day or placebo. Medications were maintained until the end of week eight, were then tapered over two weeks and patients were monitored off medications during the last study week. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow-back method.

resultsThere was no significant difference between treatment groups in the proportion of participants who achieved 3 weeks of abstinence during the maintenance phase of the trial (27.9% for the medication group and 29.5% for the placebo group), although both groups showed a reduction over time.

conclusionsBased on this treatment study, the combined intervention did not show promise as a treatment for cannabis use disorder.

Indexed as

AdolescentAdultCannabinoid Receptor AgonistsClonidineCravingDouble-Blind MethodDronabinolDrug MonitoringFemaleHumansMaleMarijuana AbuseMiddle AgedNarcotic AntagonistsSecondary PreventionSubstance Withdrawal SyndromeCannabinoid Receptor AgonistsClonidineDronabinollofexidineNarcotic AntagonistsCannabis use disorderCannabis withdrawalDronabinolLofexidineMarijuana dependenceMarinol

Identifiers

PMID26711160
PMCPMC4729291
OpenAlexW2174050801

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.